Marksman Healthcare
  • About Us
  • Services
    • HEOR
    • RWE
    • Medical Affairs
    • Competitive Intelligence
    • Advanced Analytics
    • Scientific Communications
  • AI Excellence
  • Case Studies
  • Publications
  • Blog
  • Marksman Academy
    • HEOR Certification
    • AI for Medical Writing
Contact Us

Home

About us

Services

heor

Rwe

medical affairs

Competitive intelligence

advanced analytics

scientific communications

AI Excellence

case studies

publications

Blogs

HEOR Certificationheor Certification

AI for Medical Writing

Contact

  • LinkedIn
  • Twitter
  • YouTube

Case studies

END-TO-END SUPPORT
  • Exploring the efficacy, safety, impact on quality of life, and economic outcomes of different forms of IV iron

    view case study

    Intravenous (IV) iron supplementation is the preferred treatment option for managing severe iron deficiency (ID) and ID anemia. Three of the available IV iron preparations are ferric derisomaltose (FDI), ferric carboxymaltose (FCM), and iron sucrose (IS). However, FCM has been reported to be associated with a high incidence of symptomatic hypophosphatemia. Our client wanted to understand the efficacy, safety, impact on quality of life, and economic outcomes of treatment of ID with FDI, FCM, and IS, and intended to publish the findings in the form of a rapid health technology assessment (HTA). For this project, we provided end-to-end support, right from the stage of inception of study objectives, restructuring the research questions into PICOS headings, development of search strategy, preparing and registering the systematic review protocol, literature screening, data extraction, risk of bias assessment, reporting, and converting the research findings into a manuscript. We also managed the publication of this manuscript, including responding to peer review and editorial comments. The rapid HTA was finally published in a high-impact PubMed-indexed journal.

  • Establishing cost-effectiveness and inclusion of an immunotherapy into Ayushman Bharat

    view case study

    Our client aimed to include a novel immunotherapy for the treatment of nasopharyngeal carcinoma under the Ayushman Bharat health scheme in India. To support this, we conducted an in-depth evaluation of the burden of illness, focusing on epidemiological, clinical, and economic data for NPC in India. We carried out an SLR to gather evidence on the disease burden, healthcare resource utilization, and treatment costs. We also developed a cost-effectiveness model comparing the immunotherapy to standard care, incorporating local cost data and pivotal clinical trial outcomes. With our assistance, the client was able to successfully demonstrate the value of their product, and position their product for inclusion into the Ayushman Bharat scheme.

  • Dossier submission support to AMCP.

    view case study

    Our client sought to gain formulary inclusion for a novel biologic therapy targeting moderate to severe rheumatoid arthritis in the US managed care market. To support the AMCP dossier submission, we performed a comprehensive review of the therapeutic landscape and conducted an SLR to gather relevant efficacy, safety, and economic data. We developed a cost-effectiveness model, comparing the biologic to both branded and generic alternatives. We also performed a budget impact analyses tailored to specific health plans, highlighting potential cost savings through optimized resource utilization. With our support, the client successfully navigated the AMCP submission process, gaining formulary acceptance in several leading US health plans

  • HTA submission support to NICE

    view case study

    Our client intended to achieve inclusion of one of the newer antiresorptive therapies for the management of osteoporosis in the UK NHS, and for the same purpose was interested in establishing cost-effectiveness of this intervention in comparison with other established therapies for this indication. In this project, we were involved in the development of the project protocol, literature search strategies in multiple databases, preparation of screening sheets, screening of all pooled abstracts and full texts, mining for additional references from relevant systematic reviews, data extraction and risk of bias assessment. We also performed a Bayesian network meta-analysis for fracture outcomes, and developed an individual patient simulation Markov model to evaluate cost-effectiveness of the intervention compared to its main competitors. We also assisted our client in responding to the NICE ERG questions and updating the NMA/ Model accordingly. With our assistance, our client was able to successfully complete the NICE submission and achieve inclusion of their product in the NHS. Therapy area: Endocrinology, Metabolic, Bone health

SYSTEMATIC REVIEWS AND META-ANALYSES
  • Respiratory Syncytial Virus: Systematic Literature Review Update for Prevention

    view case study

    Respiratory Syncytial Virus (RSV) remains a significant cause of respiratory illness, particularly in vulnerable populations. For this project, our client sought support in updating a previously conducted systematic literature review (SLR) to capture the most recent evidence on an RSV preventive intervention, in preparation for a health technology assessment (HTA) submission.

    Building on the client’s existing SLR framework, we executed comprehensive database searches across PubMed, Embase, Cochrane Library, INAHTA, ClinicalTrials.gov, and WHO ICTRP, complemented by a targeted grey literature search across nine scientific conferences. Following deduplication, we prepared structured screening files and conducted dual Level 1 (title/abstract) screening of approximately 900 records, followed by full-text procurement and Level 2 screening of approximately 30 articles. Data extraction was completed for approximately 10 eligible studies using a client-provided template, ensuring consistency with prior submissions and HTA requirements.

    Therapy area: Infectious Diseases, Respiratory (RSV Prevention)

  • Diffuse Large B-Cell Lymphoma: Targeted Literature Review

    view case study

    Diffuse Large B-Cell Lymphoma (DLBCL) is one of the most aggressive forms of non-Hodgkin Lymphoma. Our client sought support in conducting a targeted literature review to identify and extract evidence from clinical trials published in the last decade that reported survival outcomes stratified by response status.

    We performed Level 1 (Title & Abstract) screening of around 900 records, followed by full-text procurement of included articles and Level 2 (full-text) screening of around 650 by applying detailed inclusion/exclusion criteria.

    Data extraction was completed for around 60 eligible studies capturing response and survival outcomes.

    Therapy Area: Hematology, Oncology

  • Non-Small Cell Lung Cancer: Systematic Literature Review

    view case study

    Non-Small Cell Lung Cancer (NSCLC) accounts for the majority of lung cancer cases worldwide and remains a leading cause of cancer-related mortality. With the growing importance of targeted therapies for specific mutations in NSCLC patients, our client sought to conduct a systematic literature review (SLR) to assess the efficacy and safety of a specific small molecule that targets BRAF mutations in locally advanced and metastatic NSCLC.

    We conducted literature searches across PubMed, Embase, INAHTA, Cochrane Library, ClinicalTrials.gov, and WHO ICTRP. The review process included Level 1 screening of around 500 records, followed by Level 2 screening of around 80 full texts. Data extraction (DE) and quality assessment (QA) were performed for around 20 articles. Key deliverables included a PRISMA 2020 flow diagram and structured screening and DE/QA outputs.

    Therapy area: Oncology, Lung Cancer

  • Acute Lymphoblastic Leukemia: Clinical and Economic Evidence Synthesis

    view case study

    Evidence generation is essential to build robust clinical and economic value stories in healthcare. For this project, our client sought support in extracting data from a predefined set of articles and classifying evidence levels for both clinical and economic endpoints.
    We extracted data from the provided article list and organized it into two consolidated outputs: clinical and economic evidence. Each study was classified by level of evidence, and risk-of-bias (RoB) assessments were conducted using appropriate tools tailored to clinical studies, including Cochrane RoB v2.0, ROBINS-I, JBI checklist, and ROBIS. A consolidated Quality Assessment form was also delivered in Excel to ensure transparent reporting of clinical evidence.
    This structured approach provided the client with comprehensive, quality-checked evidence tables that strengthened the integration of both clinical and economic perspectives for informed decision-making.

    Therapy area: Hematology, Oncology

  • Prostate Cancer: Systematic Review of Symptom-Related Outcomes

    view case study

    Prostate cancer continues to be a critical focus in oncology research, with growing attention on understanding patient symptoms and related clinical endpoints. For this project, our client sought support in systematically screening evidence on symptom-related outcomes in prostate cancer patients.
    We reviewed approximately 2,500 articles during L1 screening, followed by Level 2 screening of around 900 full texts for detailed information on symptoms and symptom-related endpoints, with quality checks applied at each stage. Key deliverables included the screening outputs, and documentation of procured full-texts.

    Therapy area: Oncology, Prostate Cancer

  • HSCT eligibility: Data Extraction for Updating Previous SLR

    view case study

    Hematologic malignancies often require complex treatment strategies, with prognosis influenced by eligibility for hematopoietic stem cell transplant (HSCT). Our client sought to update a previously conducted systematic literature review to capture additional evidence about HSCT eligibility.

    We conducted data extraction of approximately 200 records, including randomized controlled trials with one arm of interest, single-arm trials, and observational studies. Data extraction was focused on interventions of interest in the overall population, with subgroup results by HSCT eligibility to strengthen existing evidence for clinical and strategic decision-making.

    Therapy area: Hematology, Oncology

  • Systematic Review in Rare Diseases: ISM, ASM, and GIST

    view case study

    Indolent systemic mastocytosis (ISM), advanced systemic mastocytosis (ASM), and gastrointestinal stromal tumors (GIST) are rare but complex conditions, often driven by mutations in the KIT and PDGFRA pathways. Our client sought to systematically review the clinical evidence on safety and efficacy across these three indications.

    For this project, we screened approximately 500 records and 200 full texts across each indications. We also developed separate PRISMA 2020 flow diagrams for ISM, ASM, and GIST to support condition-specific evidence synthesis.

    Therapy area: Oncology, Rare Diseases

  • Oncology Biomarker Testing: Evaluating the Cost-Effectiveness of Next-Generation Sequencing (NGS)

    view case study

    Next-Generation Sequencing (NGS) plays a pivotal role in biomarker-driven oncology by enabling testing of multiple gene variants and streamlining access to targeted treatments. Our client sought to conduct a targeted literature review (TLR) to assess the cost-effectiveness of NGS compared to conventional testing strategies. For this project, we performed structured literature search in PubMed, Embase, and EBSCO databases. We then screened over 2000 records and 50 full-texts, prepared the template for data extraction, and extracted data from around 20 studies.

    Therapy area: Oncology, Diagnostics

  • Myelodysplastic Syndrome: Systematic Literature Review for Clinical and Economic Evaluation of Treatments 

    view case study

    Myelodysplastic syndrome (MDS) is a group of hematologic malignancies requiring timely and effective treatment to improve prognosis and quality of life. Our clients sought to conduct a systematic literature review (SLR) to evaluate clinical and economic outcomes of therapies used in newly diagnosed high risk MDS patients. We searched databases including but not limited to PubMed, EMBASE, MEDLINE and Cochrane Library. For clinical SLR, we screened approximately 9000 records, 1000 full-texts and extracted data from 30 studies while for economic SLR, we screened ~3500 records, 100 full-texts and extracted data from 25 studies. We also conducted quality assessment for both domains. 

    Therapy area: Oncology

  • Ulcerative Colitis and Crohn’s Disease: Placebo Remission Assessment in Randomized Clinical Trials for Advanced Therapies

    view case study

    Understanding placebo remission rates can help in interpreting trial results and benchmarking for efficacy and safety of advanced therapies in Ulcerative Colitis (UC) and Crohn’s Disease (CD). Our client sought to conduct a two systematic literature reviews (SLR) of clinical trials of advanced therapies for UC and CD. We conducted a comprehensive database search from PubMed, EMBASE, MEDLINE and Cochrane Library. For UC we screened approximately 3500 records, 600 full-texts and extracted data from 40 studies whereas for CD SLR we screened 700 records, 100 full-texts and extracted data from 20 studies. We also carried out the quality assessment for each extracted study.  

    Therapy area: Autoimmune 

  • Stage I NSCLC: Targeted Literature Review on Unmet Needs

    view case study

    Early stage non-small cell lung cancer (NSCLC) presents a unique clinical landscape with evolving therapies and distinct gaps in care. Understanding the unmet needs to inform future treatments and clinical decision making is important.

    Our client sought to conduct a targeted literature review (TLR) to assess unmet needs in stage I NSCLC to support value communication and strategic planning. The review process included screening of approximately 2500 record, 300 full-texts and extracted data from 30 studies along with their quality assessments for clinical and economic outcomes.

    Therapy area: Oncology

  • Retained Surgical Items: Targeted Literature Review to Support Claims Update for Surgical Safety Technology

    view case study

    Retained surgical items (RSIs) are serious complications that occur during operative procedures leading to increased morbidity and healthcare costs with extended hospital stays however, they are preventable. Technologies to prevent RSIs are critical to enhance patient safety and surgical outcomes.

    Our client sought to conduct targeted literature review (TLR) to evaluate available technologies designed to reduce foreign body retention risk during surgeries. We searched major databases including PubMed, EMBASE, MEDLINE and Cochrane Library, screening approximately 400 records, 60 full-texts and extracted data from 30 studies for quality assessment.

    Therapy area: Surgery

  • Postmenopausal Osteoporosis: Updated Evidence Review and HTA Support

    view case study

    Osteoporosis in postmenopausal women is a significant public health concern that elevates risk of fracture. We had previously supported our client in the HTA submission for the inclusion of an antiresorptive therapy in the UK NHS. As new evidence emerges, our client sought to update the previous evidence we generated in three systematic literature reviews (SLRs) focusing on clinical effectiveness, economic outcomes and humanistic outcomes.

    We conducted updated literature search across databases from PubMed, MEDLINE, Cochrane Library and HTA websites. For clinical SLR update, we screened approximately 200 records, 25 full-text articles and extracted data from 10 studies. The economic SLR update involved 1200 record screening, 25 full text articles and extracted data from 3 studies. The humanistic SLR update included screening of 150 records, 30 full-texts and extracted data from 5 studies. We also conducted quality appraisal across all domains. We also supported with network meta-analysis (NMA), cost-effectiveness (CE) modelling aligned with HTA requirements.

    Therapy area: Endocrinology, Metabolic, Bone health

  • Type I Diabetes Mellitus (T1DM): Comparing Efficacy of Long-Acting Insulins

    view case study

    Type 1 Diabetes Mellitus (T1DM) is caused by autoimmune destruction of pancreatic beta cells requiring lifelong insulin therapy, accounting for 5-10% of all diabetes cases. Optimizing long-acting insulin regimens is important for minimizing adverse events, managing glycemic control and improving patient outcomes.

    Our client sought to systematically review randomized clinical trials (RCTs) and synthesize evidence comparing two long-acting insulin analogs in T1DM patients. We conducted a comprehensive search across PubMed, EMBASE, Cochrane Library, ANZCTR, ClinicalTrials.gov and WHO ICTRP, screening approximately 1000 records, 85 full-texts and extracting data from ~50 studies for quality appraisal.

    Therapy area: Metabolic, Diabetology

  • PD-1 inhibitor monoclonal antibody: Efficacy, safety, cost-effectiveness, and impact on quality of life on Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma

    view case study

    Programmed cell death protein-1 (PD-1) is a cell surface receptor on certain T and B cell subtypes that has a role in immune-mediated killing of certain cancer cells. It has been observed that inhibiting PD-1 can result in increased killing of cancer cells, and thus, PD-1 inhibitors have been investigated as targeted therapy for various cancers. One such PD-1 inhibitor has been shown to have activity against several cancers, including Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma, and has already been approved by the USFDA for these indications. Our client was interested in understanding the efficacy, safety, cost-effectiveness, and impact on the quality of life of this PD-1 inhibitor molecule in different types of cancer. For this project, we assisted our client by screening and abstracting relevant articles from nearly 550 records over two rounds of screening. We also were involved in data extraction and quality assessment from over 50 records.
    Therapy area: Oncology

  • Neovascular Age-Related Macular Degeneration: Generating evidence surrounding various outcomes for the available treatment options

    view case study

    Neovascular Age-Related Macular Degeneration (nAMD) is a progressive ocular disease characterized by the abnormal growth of new blood vessels in the choroid, leading to retinal damage and central vision loss. This pathological neovascularization results in leakage, hemorrhage and fibrosis which ultimately disrupts the macula along with the central portion of the retina responsible for detailed vision. Agents targeting VEGF (vascular endothelial growth factor) administered intravitreally have revolutionized the treatment of nAMD. Our client wanted to understand the efficacy and safety of different anti-VEGF medications used in the management of nAMD. To address this, we conducted a comprehensive data extraction and risk of bias assessment of over 70 studies. This project stood out by the large number of linked publications that some of the included studies had. We extracted data pertaining to efficacy, safety, and tolerability, and also performed risk of bias assessment for all the included articles.
    Therapy area: Therapy Area: Ophthalmology

  • Stent Devices: Comparison of Clinical Outcomes

    view case study

    Coronary artery disease (CAD) is a leading cause of death worldwide. When plaque buildup narrows a coronary artery, restricting blood flow to the heart, stenting offers a minimally invasive solution to restore blood flow and prevent heart attacks. However, choosing the optimal stent type for each patient is crucial to maximize the clinical benefit. Our client wanted to compare the clinical performance of various stent devices. To achieve this, we performed data extraction from over 60 relevant studies focusing on patient-centric clinical outcomes like Amputation-Free Survival (AFS) and freedom from Clinically-Driven Target Lesion Revascularization (CD-TLR).
    Therapy area: Cardiovascular

  • Robotic Surgery: Understanding Device Usage

    view case study

    Robotic surgery utilizes advanced robotic systems to perform minimally invasive procedures with high precision, flexibility, and control. Staplers in robotic surgery are essential tools that enable surgeons to efficiently cut and staple tissues simultaneously, enhancing surgical outcomes and reducing recovery times. Our client wanted to evaluate the impact of using different types of surgical staplers in various robotic surgeries. In this project, we performed data extraction on over 110 studies identified through a prior literature review. This analysis helped our client develop an understanding surrounding the usage of their staplers in different robotic surgeries, potential advantages, and factors influencing the choice of their staplers over their competitors.
    Therapy area: Robotic Surgery

  • Multivessel coronary artery disease (MVD): Optimizing Treatment Strategies

    view case study

    Multivessel coronary artery disease (MVD) occurs when there is luminal stenosis of at least 70% in at least two major coronary arteries. It is estimated to occur in 45% to 88% of men with angina, and has around 3-times higher mortality hazard compared to single vessel disease. Optimal revascularization strategy for MVD using either percutaneous coronary intervention (PCI) or coronary arterial bypass grafting (CABG) often depends on the complexity of coronary anatomy, patient comorbidities, operator experience, and patient preferences/ expectations. Our client aimed to update the understanding of the latest research to optimize treatment strategies for MVD. In this project, we extracted data from nearly 50 records based on a data extraction template provided to us by the client, helping our client to draw insights on the factors affecting treatment strategies for MVD.
    Therapy area: Cardiolog

  • Non-muscle invasive bladder cancer (NMIBC): Navigating Treatment Landscape in the Real-world

    view case study

    Non-muscle invasive bladder cancer (NMIBC) is a malignancy of the urothelial cells in the urinary bladder that has not yet infiltrated the muscular wall. NMIBC is the most common type of bladder cancer and is classified as a non-organ-confined disease. Despite being non-invasive, NMIBC carries a high risk of recurrence and progression to muscle-invasive disease, highlighting the need for close monitoring and potential adjuvant treatment strategies. Selecting the most effective treatment requires understanding not only established options but also how they perform in real-world settings. Our client was interested to understand the treatment landscape of NMIBC in the real-world setting. To achieve this, we assisted our client by screening around 200 records followed by data extraction from around 20 records with a focus on treatment types, effectiveness, safety, and patient characteristics.
    Therapy area: Oncology, Urology

  • Multiple Myeloma: Assessing Efficacy, Safety, and Quality of Life of Various Treatment Strategies

    view case study

    Multiple myeloma (MM) is a spectrum of related disorders associated with clonal proliferation of plasma cells within bone marrow leading to the accumulation of monoclonal paraproteins (M-proteins) with incomplete immunoglobulin chains. Patients with MM not only suffer from the detrimental effects of the accumulated M-proteins in various organ systems, but also experience bone destruction and the resulting pathologic fractures. Treatment options depend on the specific disorder and the stage of illness, and usually include watchful waiting, surgery when feasible, hematopoietic cell transplant, radiation therapy, and chemotherapy. Our client wanted to assess the outcomes of various available treatment strategies for MM with an intention to understand the optimum treatment strategy. For this project, we performed screening of 500 records followed by data extraction of nearly 200 records, focusing on treatment efficacy, safety, and impact on the patient’s quality of life.
    Therapy area: Oncology, Hematology

  • Graft-versus-Host Disease (GvHD): Assessing the Burden of Disease, and the Efficacy and Safety of Treatment Options

    view case study

    Graft-versus-Host Disease (GvHD) is a serious complication that can occur after a hematopoietic stem cell transplantation, where the grafted immunocompetent donated cells recognize the host tissues as ‘foreign’ and mount an immunological attack. This attack typically occurs within the first 100 days after the transplant, and the damage can be seen in various organs, including the skin, gastrointestinal tract, liver, and lungs. GVHD can be acute or chronic, each with distinct clinical presentations and management strategies. Our client was particularly interested in understanding the economic burden of GvHD, and the current treatment landscape. We assisted our client by screening nearly 50 records to identify the records with the most relevant information, and data extraction from around 10 records.
    Therapy area: Hematology, Immunology

  • Acute myeloid leukemia (AML): Efficacy, Safety, and Cost-Effectiveness of available treatment options

    view case study

    Acute myeloid leukemia (AML) is a highly aggressive hematological malignancy characterized by the clonal expansion of immature myeloid precursors in the bone marrow, leading to disruption of normal hematopoiesis. This uncontrolled proliferation results in cytopenias, increased risk of infections, and bleeding complications. Heterogeneity in the underlying genetic mutations and cytogenetic abnormalities in AML necessitates a personalized and multimodality treatment approach. Selecting optimal treatment regimens requires a nuanced understanding of the therapeutic landscape, encompassing established therapies, emerging targeted agents, as well as the efficacy, safety, long-term toxicities, and cost-effectiveness of these treatment options in real-world settings. Our client wanted to navigate this complex landscape of AML treatment through a multifaceted analysis. To assist our client, we screened around 400 records to identify the studies containing the most relevant information, followed by data extraction of 100 records using the data extraction grid shared by the client.
    Therapy area: Oncology, Hematology

  • Myelodysplastic Syndromes (MDS): Efficacy and Safety of Available Treatment Options

    view case study

    Myelodysplastic syndromes (MDS) represent a heterogeneous group of clonal hematopoietic stem cell malignancies characterized by ineffective hematopoiesis, cytopenias, and a concerning predisposition to evolve into acute myeloid leukemia (AML). The intricate pathogenesis of MDS involves a multifaceted interplay between genetic and epigenetic alterations within hematopoietic stem and progenitor cells (HSPCs). These aberrations disrupt normal differentiation pathways, escalate apoptosis (programmed cell death), and ultimately culminate in bone marrow failure. Our client was interested in assessing the outcomes associated with the established therapies as well as evolving treatment strategies for MDS, with an emphasis on real-world effectiveness and safety profiles. To address this, we meticulously screened over 300 records to identify relevant publications encompassing both interventional trials and real-world evidence sources. From this initial screening, we performed data extraction from nearly 150 records.
    Therapy area: Hematology

  • Relapsed or refractory multiple myeloma (RRMM): efficacy and safety of available therapies

    view case study

    Multiple myeloma (MM) is a cancer of plasma cells originating in the bone marrow. Different stages of MM include “Refractory myeloma” which is non-responsive to therapy or progresses within 60 days of the last line of therapy; “Relapsed myeloma” in which previously treated myeloma progresses after prior therapy and requires new therapy; and “Relapsed and refractory multiple myeloma (RRMM)” is disease that is nonresponsive to the chosen line of therapy in patients who had achieved a minimal response or better at some point previously in their disease. Our client aimed to understand how different drugs impact RRMM patients, especially surrounding clinical efficacy of the drugs (survival and response rates), their impact on the quality of life, and their economic outcomes, in both controlled as well as real-world settings. To address this requirement, we screened around 600 records to identify the most relevant publications, and extracted data from nearly 200 records.
    Therapy area: Oncology, Hematology

  • Advanced NSCLC: Safety, Survival, and Response of 2nd Line and Beyond Therapies

    view case study

    Non-small cell lung cancer (NSCLC) represents the most prevalent form of lung cancer, accounting for approximately 80-85% of all lung cancer diagnoses. While targeted therapies have revolutionized first-line treatment for advanced/ metastatic NSCLC, patients often experience disease progression, necessitating subsequent treatment lines (2L+). Our client wanted to explore the landscape of evidence surrounding the efficacy and safety of FDA/EMA-approved 2L+ therapies for this patient population, drawing insights from clinical trial data. In this project, we extracted data from nearly 100 records with a focus on safety, survival, and response outcomes.
    Therapy area: Oncology

  • Uncontrolled Type 2 Diabetes Mellitus: A Comparative Analysis of Basal Insulins

    view case study

    A significant proportion of patients suffering from type 2 diabetes mellitus (T2DM) eventually experience insufficient glycemic control with oral antidiabetic drugs and require insulin therapy. Various types of insulin are available, including rapid-acting, short-acting, intermediate-acting, and long-acting formulations, each tailored to different glycemic needs and patient lifestyles. Insulin can be administered in different strategies, such as basal, basal-bolus, twice-daily, split-mixed, etc. Our client wanted to perform a comparative efficacy and safety assessment of dual-action basal insulin medications in managing uncontrolled T2DM in patients who have already failed previous anti-diabetic therapies. We assisted our client by doing the data extraction of 20 records using the data extraction sheet provided by the client.
    Therapy area: Metabolic, Diabetology

  • Moderate-to-severe plaque psoriasis (PsO): A Comparative Analysis of Biosimilars of TNF inhibitors

    view case study

    Psoriasis is a chronic autoimmune inflammatory disease that affects millions of people worldwide. Moderate-to-severe plaque psoriasis (PsO) manifests as thick, red, scaly plaques that can significantly impact patients’ quality of life. Tumor necrosis factor inhibitors (TNFi) have revolutionized PsO treatment, demonstrating remarkable efficacy. However, with the expiration of patents on some TNFi drugs, biosimilars have emerged as a potentially cost-effective alternative. Our client was interested in investigating the landscape of evidence surrounding the relative efficacy and safety of TNFi and biosimilars for patients with moderate-to-severe PsO in clinical trials. In this project, we helped our client to perform data extraction of around 150 records using the data extraction grid provided by the client.
    Therapy area: Dermatology

  • Interstitial pulmonary fibrosis (IPF): Epidemiologic, clinical, humanistic, and economic burden

    view case study

    Interstitial pulmonary fibrosis (IPF) is a chronic, progressive lung disease characterized by the thickening and scarring of lung tissue, leading to a decline in lung function. The exact cause of IPF is unknown, and its symptoms, which include shortness of breath and a persistent dry cough, typically worsen over time. Understanding the burden of IPF is crucial for developing effective management strategies and improving patient outcomes. Our client wanted to explore the epidemiologic, clinical, humanistic, and economic burden of IPF. For this project, we assisted our client in gathering relevant data by screening of nearly 10,000 records over two stages to identify the most relevant records containing the information of interest.
    Therapy area: Respiratory

  • Major Depressive Disorder: Generating evidence surrounding various outcomes

    view case study

    Major Depressive Disorder (MDD) is a mood disorder marked by a persistent (at least 2 weeks) low mood and loss of pleasure. Neurotransmitters like serotonin and norepinephrine are likely involved, and prominent risk factors include genes and environmental influences. Symptoms can include sleep problems, weight changes, fatigue, trouble thinking, and suicidal thoughts. Our client needed a deeper understanding of how different treatments for MDD impacted the lives of the patients. To achieve this, we performed data extraction from over 80 relevant studies that focused on the influence of various available interventions on economic burden, quality of life, suicidal ideation, anxiety, self-harm risk, and mortality.
    Therapy area: Psychiatry

  • Exploring available therapies for narcolepsy: Evaluating their effectiveness and safety

    view case study

    Narcolepsy, a neurological disorder marked by persistent daytime sleepiness and unpredictable episodes of sudden sleep onset, significantly disrupts daily activities for those affected. Managing this condition involves a multifaceted approach, combining pharmacological, behavioral, and immunotherapy options. Addressing our client’s interest in understanding the efficacy and safety of the available narcolepsy medications, and the impact in patient’s quality of life and other outcomes, we conducted a comprehensive analysis, extracting data from 150 articles using a predefined grid for this project.
    Therapy area: Neurology

  • Moderate-to-severe Plaque Psoriasis: Assessing the evidence on available therapies for effectiveness and safety

    view case study

    Plaque psoriasis is a chronic skin condition characterized by the presence of thick, red, and scaly patches on the skin, and can impact the patient’s quality of life, especially those who have moderate-to-severe form of the disease. In fact, these individuals often experience more extensive skin involvement compared to the mild form, with the plaques covering a larger percentage of their body surface area. Managing this condition typically involves topical and systemic treatments to alleviate symptoms and minimize daily life impact.

    Our client was interested in summarizing the published data on the effectiveness, safety and Quality of life outcomes of approved biologics and their biosimilars for adults with chronic moderate-to-severe plaque psoriasis within real-world studies. For this project, we extracted data from 200 articles using a pre-specified data extraction grid.
    Therapy area: Dermatology

  • Relapsed or refractory multiple myeloma (RRMM): clinical, humanistic, and economic outcomes of systemic pharmacological anti-cancer therapies

    view case study

    Multiple myeloma (MM) is a hematologic malignancy characterized by abnormal clonal B-cell growth in the bone marrow, resulting in various complications such as hypercalcemia, renal impairment, anemia, bone fractures, and increased susceptibility to infections. One particularly challenging phase of the disease is known as relapsed or refractory multiple myeloma (RRMM). RRMM is defined as a condition where the disease continues to advance despite attempts at salvage therapy or within 60 days of the last treatment, even in patients who initially showed at least a minimal response to treatment. An even more formidable subset within RRMM is referred to as triple class refractory (TCR) MM. TCR MM signifies disease progression after receiving treatment with a proteasome inhibitor, an immunomodulatory drug, and a CD-38 antibody.

    Our client was interested in gathering evidence about the clinical, humanistic, and economic outcomes of systemic pharmacological anti-cancer therapies when used in the management of RRMM. In addition to clinical trial evidence, our client was also interested in gathering evidence from published real-world evidence (RWE) studies. For this project, we screened over 400 articles for relevant records and extracted data from over 60 articles using a pre-specified data extraction grid.
    Therapy area: Oncology

  • Acute myeloid leukemia (AML): clinical, economic, and humanistic outcomes surrounding newly diagnosed AML treated with non-intensive chemotherapy

    view case study

    Acute myeloid leukemia (AML) is distinguished by an uncontrolled proliferation of myeloid blasts within the bloodstream, bone marrow, and possibly other tissues. Symptoms of AML may include fatiguability, easy bruising and bleeding, shortness of breath, and increased risk of infection. AML can occasionally spread to skin, brain, or gums. Being an acute leukemia, AML is characterized by rapid progression, and if left untreated, is typically fatal within weeks or months.

    Our client was interested in compiling comprehensive evidence encompassing clinical, economic, and humanistic outcomes surrounding newly diagnosed AML treated with non-intensive chemotherapy This information was intended to bolster future health technology assessment (HTA) submissions for a novel product to treat AML. For this project, we conducted a rigorous two-level screening of around 11,000 articles, based on the eligibility criteria drafted by the client and and identified the records that contained the most relevant information pertaining to the objectives of the review.
    Therapy area: Oncology

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC): clinical, humanistic, and economic outcomes

    view case study

    Metastatic Castration-Resistant Prostate Cancer (mCRPC) is a highly aggressive manifestation of prostate cancer. In this advanced stage, cancer cells exhibit a remarkable capacity to proliferate and metastasize, even when hormonal therapy is no longer effective, posing significant management challenges. mCRPC is frequently linked with reduced survival rates, as it tends to progress rapidly and develop resistance to conventional treatment modalities. Ongoing research endeavors are dedicated to pioneering novel therapies and targeted interventions aimed at enhancing the prognosis and overall quality of life for individuals grappling with this formidable and insidious disease. With a focus on early detection, personalized treatment strategies, and the continual advancement of medical science, there is a glimmer of hope in the battle against mCRPC, offering optimism to those confronted by this complex condition.

    Our client was interested in generating a comprehensive evidence base surrounding clinical, economic, and humanistic outcomes of adult patients with mCRPC. For this project, we conducted screening of around 4,000 articles across two levels and extracted relevant data from over 100 records, using the data extraction template shared by the client.
    Therapy area: Oncology

  • Diffuse Large B-Cell Lymphoma (DLBCL): clinical, humanistic, and economic outcomes

    view case study

    Diffuse Large B-Cell Lymphoma (DLBCL) stands as the most prevalent subtype of Non-Hodgkin Lymphoma (NHL), comprising approximately 31% of newly diagnosed cases. This aggressive form of lymphoma originates in B cells, a type of white blood cell responsible for immune response regulation. DLBCL is characterized by its rapid growth and can manifest in various parts of the body, including the lymph nodes, spleen, and bone marrow. Prompt diagnosis and treatment are crucial, as the condition can progress swiftly. Advances in medical research and therapy options continue to improve outcomes for DLBCL patients, underscoring the importance of ongoing research in the field.

    Our client was interested in generating evidence surrounding clinical, humanistic, and economic outcomes for stem cell therapy-ineligible DLBCL patients beyond second-line therapy. For this project, we conducted a rigorous screening of around 11,000 articles across two levels at break-neck speed and extracted relevant data from approximately 200 records using the data extraction template shared by the client.
    Therapy area: Oncolog

  • Gastroparesis and cyclic vomiting syndrome: epidemiology, treatment patterns, and economic burden

    view case study

    Gastroparesis is a chronic disorder due to weak peristalsis of the stomach muscles, characterized by delayed stomach emptying without a blockage, and usually presents with nausea, heartburn, vomiting, early satiety, and boating sensation. Cyclic vomiting syndrome (CVS) is a rare gastrointestinal disorder characterized by recurrent episodes of severe vomiting that occur at regular intervals, typically with symptom-free periods in between; the underlying cause of CVS is not fully understood, but it is thought to be related to abnormal functioning of the nervous system and gastrointestinal tract.

    Our client was interested to generate evidence surrounding epidemiology, treatment patterns, and economic burden of gastroparesis and CVS. For this project, we extracted data from over 50 articles in the extraction template provided by the client.
    Therapy area: Gynaecology

  • Uterine fibroids: clinical, humanistic, and economic outcomes of available treatment options

    view case study

    Uterine fibroids (UFs) are the most common benign tumors in women, affecting up to 70–80% of women by the age of 50. The symptoms of these monoclonal tumors that originate from uterine smooth muscle include abnormal uterine bleeding, including heavy menstrual bleeding leading to anemia, pelvic pain, reproductive dysfunction, and obstetric complications. UFs are also associated with significant impact on the quality of life.

    Conventional management options for UFs include hysterectomy, uterus-sparing interventions such as myomectomy, endometrial/ radiofrequency ablation, and uterine artery embolization. Medical management is usually preferred by women who desire future pregnancy, and include gonadotropin antagonists such as relugolix, progestin modulators such as mifepristone and ulipristal, and certain off-label medications. Nevertheless, medical management of UFs still remain an unmet need.

    Our client was interested in updating an existing three-volume systematic literature review surrounding the clinical outcomes, humanistic outcomes, and economic impact of different treatment options for UFs, following the NICE template. For this project, we provided end-to-end support, beginning from executing search strategy, preparing screening sheets, screening over 800 records over 2 rounds including published articles, conference abstracts, and clinical trial records, preparing data extraction template, extracting data from around 20 records, performing quality assessment, and updating the three SLR reports including rectifying a few inconsistencies.
    Therapy area: Gynaecology

  • Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA): long-term clinical outcomes

    view case study

    Hematopoietic stem cell transplant (HSCT) is often performed as a treatment modality for cancers involving blood or bone marrow, including multiple myelomas and various forms of leukemias. One of the complications following HSCT is thrombotic microangiopathy (TMA), in which there is endothelial injury due to multiple factors, leading to microangiopathic hemolytic anemia, intravascular platelet activation, and formation of thrombi within the microcirculation. HSCT-TMA is associated with end-organ injury involving kidney, lungs, and gastro-intestinal tract among others, primarily due to ischemia and activation of complement cascade.

    Our client was interested to understand the mortality, survival, and other long-term outcomes among patients with HSCT-TMA. For this project, we performed literature screening of nearly 1400 articles over 2 rounds and identified the records that contained the most relevant information pertaining to the objectives of the review.
    Therapy area: Oncology, Hematology

  • B-cell non-Hodgkin lymphoma: adverse event profile of existing therapies

    view case study

    Non-Hodgkin lymphoma (NHL) can arise from both hematopoietic and lymphoid tissues (typically in the bone marrow), including B, T, and natural killer cells. Within B-cell NHL (B-NHL), there are several subtypes, including DLBCL (diffuse large B-cell lymphoma), FL (follicular lymphoma), MCL (mantle cell lymphoma), MZL (marginal zone lymphoma), SLL (small lymphocytic lymphoma), PMBCL (primary mediastinal B-cell lymphoma), and HGBCL (high-grade B-cell lymphoma), to name a few. Treatment of B-NHL includes traditional chemotherapy and immunotherapy regimens; various newer treatment modalities including CAR-T therapy, small molecules and bispecific antibodies are in various phases of development.

    Our client was interested to understand the adverse event profile of all available treatment modalities for B-NHL, stratified by the subtypes of B-NHL, to update an existing systematic literature review. For this project, we performed screening of over 2400 articles through two levels. We also performed preliminary data extraction from around 100 records and full data extraction from around 30 records using the data extraction template shared by the client.
    Therapy area: Oncology, Hematology

  • Sjögren’s Syndrome: Epidemiology, Clinical, Economic, and Humanistic Burden

    view case study

    Sjögren’s syndrome is a female-predominant systemic autoimmune rheumatic disease characterized by ‘sicca symptoms’ involving symptoms due to dryness most often involving the eyes and mouth, that develops as a result of inflammation of the lacrimal and salivary glands. Extra-glandular manifestations of Sjögren’s syndrome may include the joints, skin, lungs, gastrointestinal (GI) tract, nervous system, and kidneys. Sjögren’s syndrome is also the second most common rheumatic autoimmune disorder, and is traditionally classified as primary or secondary, depending on the absence or presence of other major autoimmune diseases.

    Our client was interested in exploring the epidemiology, clinical, economic, and humanistic Burden of illness in patients with Sjögren’s syndrome. For this project, we assisted our client by extracting data pertaining to epidemiology from over 120 articles using the data extraction template provided by the client.
    Therapy area: Rheumatology

  • Multiple myeloma: clinical, economic, and humanistic burden

    view case study

    Multiple myeloma (MM), also known as plasma cell myeloma, is a neoplasm involving plasma cells, and is associated with substantial morbidity and mortality resulting from end organ damage, such as renal impairment, anemia, hypercalcemia, and lytic bony lesions. Treatment for MM has evolved from therapies such as autologous stem cell transplant in the 1980s, the IMIDs (including thalidomide and lenalidomide) and proteasome inhibitors in the 1990s and 2000s, and has more recently included monoclonal antibodies (daratumumab and elotuzumab) and histone deacetylating agents (panobinostat). All said, MM is still considered treatable, but generally incurable.

    Our client was interested in understanding the clinical, economic, and humanistic burden of MM, and safety profile of available treatment options, in the real-world setting across the world. For this project, we assisted our client in gathering relevant data by screening through over 1500 articles (including nearly 250 conference abstracts/ posters). We also extracted data from over 60 relevant records pertaining to the disease burden of relapsed and refractory MM, in the data extraction template shared by the client.
    Therapy area: Oncology, hematology

  • Schizophrenia: hospitalization after using long-acting injectable second-generation antipsychotics

    view case study

    Antipsychotic drugs are the mainstay in the management of schizophrenia, but are associated with challenges such as unpleasant adverse effects and poor adherence rates, also stemming from the disbelief on the patients’ side of having an illness (which is common in schizophrenia). To overcome these challenges, long-acting injectable (LAI) antipsychotic drugs were developed: these can be administered at intervals of 2 to 4 weeks or even longer. The LAI versions of second-generation antipsychotics (SGA) have been associated with reduced relapse rates and reduced hospitalization outcomes.

    Out client was interested to perform a network meta-analysis of LAI-SGAs vs other SGAs with a focus on outcomes related to hospitalization. For this project, we evaluated nearly 3600 records over 2 rounds of screening to identify the most relevant records that contained the outcomes of interest for performing the NMA.
    Therapy area: Psychiatry

  • Chronic kidney disease (CKD): epidemiology, economic, clinical, and humanistic burdens

    view case study

    Left untreated, chronic kidney disease (CKD) can result in complications such as hypertension, cardiovascular disease (including left ventricular hypertrophy, diastolic and systolic dysfunction, valvular disease, dysrhythmias, and heart failure), anemia, mineral bone disorder, salt and water retention, electrolyte disorders including metabolic acidosis, and uremic symptoms including anorexia, fatigue, cachexia, pruritus, nausea, restless leg syndrome, sleep disturbances, and sexual dysfunction.

    Our client was interested to understand the epidemiology, economic, clinical, and humanistic burdens of CKD and its different stages, including patients with ESRD (end-stage renal disease), renal transplant recipients, and CKD patients undergoing dialysis. For this project, we evaluated around 3900 records over 2 rounds of screening and identified the records containing the most relevant information.
    Therapy area: Nephrology

  • Chronic lung allograft dysfunction (CLAD): humanistic outcomes

    view case study

    Lung transplant has been shown to improve the health-related quality of life (HRQoL) among patients with end-stage lung disease arising from various conditions. However, development of chronic lung allograft dysfunction (CLAD) can considerably affect the HRQoL. Two subtypes of CLAD have been defined: the obstructive form, Bronchiolitis Obliterans Syndrome (BOS), and the restrictive form, Restrictive Allograft Syndrome (RAS).

    Our client was interested in evaluating the humanistic outcomes pertaining to CLAD, BOS, and RAS. For this project, we extracted data from around 20 full texts identified by the client in a detailed data extraction template shared by the client.
    Therapy area: Pulmonology, Transplantation medicine

  • Vasomotor symptoms (VMS): clinical, economic, and humanistic burden, and unmet needs

    view case study

    Vasomotor symptoms (VMS), also referred to as hot flashes, hot flushes, and night sweats, are the hallmark symptoms of menopause. The occurrence of VMS is common in midlife women; emerging data suggest that VMS may also persist into old age for some women. The frequency and severity of VMS vary widely among women, and as a result, VMS significantly impacts the lives of perimenopausal, menopausal, and postmenopausal women. Though hormonal therapy is used for VMS management, usage of hormonal therapy is also associated with considerable amount of risk.

    Our client was interested to characterize the burden and unmet need resulting from VMS in perimenopausal, menopausal, and postmenopausal women, and to describe the impact of VMS on fatigue, anxiety and depression among all women residing in the USA. For this project, we evaluated over 4,400 records over 2 rounds of screening and identified the most suitable records to inform two different SLRs about VMS.
    Therapy area: Endocrinology, Women’s health

  • Safety of JAK inhibitors in autoimmune disorders: systematic literature review of ITCs, NMAs, and MAs

    view case study

    Janus kinase inhibitors (JAKis) are being investigated for their efficacy and safety in the management of several autoimmune disorders, including rheumatoid arthritis (RA), atopic dermatitis (AD), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-AxSpa), Crohn’s disease (CD), ulcerative colitis (UC), and psoriatic arthritis (PsA).

    Our client was interested in compiling evidence about the safety of a certain second-generation JAKi when used in the management of the autoimmune conditions mentioned above. Specifically, since direct head-to-head comparisons of this molecule with other comparators are scarce, our client wanted to focus on extracting data from published indirect treatment comparisons (ITCs) such as network meta-analyses (NMAs). For this project, we simultaneously extracted data from 35 NMAs that were obtained from a previous targeted literature review (TLR), and also performed a fresh screening of around 3500 abstracts over 2 levels to identify 5 additional NMAs for data extraction.

    Impressed by the quality of work that we delivered in identifying and extracting data from ITCs, the client expanded the initial scope of work to include meta-analyses as well. For this expanded scope of work, we screened through around 1500 records that we had excluded in the previous rounds of screening, and identified around 30 meta-analyses that contained relevant information; we also extracted data from these 30 records.
    Therapy area: Rheumatology

  • JAK inhibitors: current pattern of usage in various conditions

    view case study

    Janus kinase inhibitors (JAK inhibitors or Jakinibs) are immune modulating medications that act by interfering with the JAK-STAT signalling pathway in lymphocytes by inhibiting the activity of enzymes belonging to the Janus kinase family (JAK1, JAK2, JAK3, TYK2). Jakinibs have been used in the treatment of inflammatory arthritides such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and various other conditions including atopic dermatitis, Crohn’s disease, and myelofibrosis. Our client was interested to understand the pattern of usage of various approved Jakinibs in different conditions. For this project, we extracted relevant data from 82 articles into a data extraction grid shared by the client.
    Therapy area: Multiple

  • Genetic dilated cardiomyopathy: incidence and prevalence

    view case study

    Dilated Cardiomyopathy (DCM) is a condition affecting the heart muscle in which one or both ventricles undergo enlargement and dilation, resulting in impaired contractility, leading to a left ventricular ejection fraction (LVEF) of < 40%. Some forms of DCM have genetic predisposition, with common associated mutations observed in the ‘cardiomyopathy genes’, namely MYH7 (β myosin heavy chain), MYBPC3 (myosin binding protein C), and TTN (titin).

    Our client was interested to explore the incidence and prevalence of genetic DCM worldwide, with special interest in the epidemiology of genetic DCM in the USA, and epidemiology of mutations in the cardiomyopathy genes. For this project, we screened through nearly 1250 records to identify the articles containing the most relevant information of interest. We also extracted data from around 50 records using the data extraction template shared by the client.
    Therapy area: Cardiology

  • Psoriatic Arthritis: evidence synthesis on the clinical, economical, and humanistic burden

    view case study

    Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that is found in about 20% of patients having psoriasis. Out of the 5 clinical subtypes of PsA, the asymmetric oligoarticular pattern is the most frequent, the others being polyarticular arthritis, distal arthritis, arthritis mutilans, and spondyloarthritis patterns. PsA is associated with considerable financial and psychological burden. With a significant progress in understanding of the disease pathogenesis, various new therapies have emerged or are in the pipeline for PsA.

    Our client wanted to have an in-depth understanding of the epidemiology, medical and clinical burden, risk factors, financial burden, healthcare resource utilization, humanistic burden, and unmet needs in PsA. For this project that was split up into three sub-projects, we screened nearly 7,000 articles from a list shared by the client to identify the most suitable records with relevant information for further data mining.
    Therapy area: Rheumatology

  • JAK inhibitors: evaluating safety while use in autoimmune disorders

    view case study

    Janus activated kinases (JAKs) are cytoplasmic tyrosine kinases that are thought to be involved in the pathogenesis of several inflammatory and autoimmune disorders. As a result, JAK inhibitors are important therapeutic targets for management of autoimmune diseases. In the context of recently observed concerns about the safety of one of the JAK inhibitors, our client wanted to have a comprehensive understanding of the safety of these agents from previously reported studies, specially related to laboratory values. For this project, we performed data curation and abstraction from almost 1000 articles and selected the studies that contained the most relevant safety information.
    Therapy area: Immune system

  • Digitizing Kaplan-Meier survival curves into CSV format

    view case study

    In oncology, Kaplan-Meier (KM) curves are extensively used for survival estimates of different treatment modalities. KM curves give a graphical understanding of different types of survival, including overall survival, progression-free survival, disease-free survival, etc. The information obtained from KM curves are used for secondary analyses, including meta-analyses and development of pharmacoeconomic models. Our client was interested in converting the information in KM curves obtained from different studies about breast cancer into digital format. For this project, we digitized almost 250 KM curves and generated coordinates of the curves in CSV format.
    Therapy area: Oncology

  • Human papilloma virus (HPV) infection: effectiveness of vaccine in prevention

    view case study

    Infection by human papilloma virus (HPV) can cause genital warts, which can progress to cervical, vulvar, and vaginal cancers. Different vaccines – bivalent, quadrivalent, and nonavalent – have a protective role against HPV-induced genital cancer. Our client wanted to evaluate vaccine effectiveness of all the 3 types of vaccine in preventing HPV infection. For this project, we curated around 2500 papers over 2 rounds of screening, based on the eligibility criteria drafted by the client and identified most relevant records containing the information of interest.
    Therapy area: Oncology, Vaccines

  • Human papilloma virus (HPV) infection: supporting development of a dynamic population model

    view case study

    Our client was interested in constructing a dynamic population model of human papilloma virus (HPV) infection and impact of vaccination. For this project, we identified model inputs by curating over 5000 potentially relevant papers through 2 rounds of screening and identified relevant articles containing information about rates of disease progression and regression, death, detection, cure, and recurrence of HPV in vaccinated and unvaccinated individuals. We also extracted data for informing the model inputs from around 150 RCTs and RWE studies, based on extraction template provided by the client.
    Therapy area: Oncology

  • Human papilloma virus (HPV) infection: exploring the natural history

    view case study

    Infection by human papilloma virus (HPV) can cause genital warts, which can progress to cervical, vulvar, and vaginal cancers. Our client was interested to understand the natural history of HPV infection affecting different locations in the body. For this project, we extracted data from 26 articles based on the data extraction grid shared by the client.
    Therapy area: Oncology

  • Atopic Dermatitis in Infants: Efficacy and safety of various treatment options

    view case study

    Atopic dermatitis (AD), or atopic eczema, is characterized by chronic, relapsing pruritic skin lesions that generally develop in early childhood, usually between 3 and 6 months of age. AD is the most common inflammatory skin condition of childhood, and around 60% of patients develop eczematous lesions in the first year of life. Treatment options include topical agents such as corticosteroids, calcineurin inhibitors, and crisaborole; systemic immunosuppressants are given off-label, and emerging therapies include topical lipoxin, omalizumab, dupilumab, nemolizumab, and barcitinib. Our client was interested to understand the safety and efficacy of various treatment options for infant AD. For this project we screened over 850 articles and selected the most appropriate articles containing the information of interest.
    Therapy area: Dermatology, Pediatric Medicine

  • Narcolepsy: clinical and patient reported outcomes

    view case study

    Narcolepsy is a neurological disorder involving dysregulated sleep-wake cycles, specially involving REM (rapid eye movement) phase, that results in excessive daytime sleepiness (EDS). Currently there is no medication that can bring about a satisfactory improvement in narcolepsy, and as a result the medication adherence of the available treatment options is often low. Our client was interested to understand the efficacy, safety, and improvements in patient-reported outcomes such as quality of life, work productivity, attention, and global impression of change, that have been reported in literature with the available treatment modalities. For this project, we abstracted around 700 research articles over 2 rounds of screening and selected the most relevant papers that contain the required information. Therapy area: Neurology

  • Spinal muscular atrophy: natural history, clinical and humanistic burden of available treatment options

    view case study

    Spinal muscular atrophy (SMA) is a rare disorder of the neuromuscular system, in which there is progressive loss of motor neurons and associated muscle wasting. SMA is due to abnormal SMN (survival motor neuron) protein, which in turn is due to a mutation in the SMN1 gene. There are 5 subtypes of SMA. There are huge variations in the natural history and treatment outcomes of SMA. Our client was interested to know the natural history of SMA, as well as the efficacy, safety, quality of life, economic burden, and health state utilities of various treatment options of SMA. For this project, we curated over 2000 articles over two levels of screening to identify the most relevant studies containing the information of interest to the client.
    Therapy Area: Neurology

  • Non-small cell lung cancer (NSCLC) with BRAF mutations: efficacy and safety of different treatment options

    view case study

    Non-Small Cell Lung Cancer (NSCLC) is the most common type of lung cancer accounting for approximately 85% of all lung cancers, and is often associated with a poor treatment outcome and high mortality. Treatment options for NSCLC include surgery, radiofrequency ablation, radiation therapy, chemotherapy, and immunotherapy. The presence of certain mutations in NSCLC enables treatment with drugs targeting the mutations. We assisted our client in generating evidence surrounding efficacy and safety of available treatment options that target advanced NSCLC variants which carry mutations in the BRAF gene, including conventional non-targeted therapy as well as targeted therapy, from the Canadian perspective, by performing data abstraction and curation through screening of around 1100 papers through 2 levels of screening, and identified 11 eligible papers from which we extracted relevant data.
    Therapy area: Oncology

  • Non-small cell lung cancer (NSCLC): clinical effectiveness of immunotherapy

    view case study

    Various immunotherapy options are now available for the management of non-small cell lung cancer (NSCLC). Our client was interested in exploring the clinical effectiveness of a specific monoclonal antibody for the immunotherapy (both mono and in combination) of advanced NSCLC. For this project, we assisted our client in evidence synthesis by screening around 1950 papers over 2 levels of screening, and subsequently extracted data from 194 studies. We also assisted in updating this SLR in the next year with by performing data abstraction from over 2000 new papers and extracting data from 92 studies.
    Therapy area: Oncology

  • Non-small cell lung cancer (NSCLC): efficacy and safety of combination therapy

    view case study

    Different treatment options are available for the management of non-small cell lung cancer (NSCLC), such as chemotherapy, radiotherapy, immunotherapy, and surgery. Frequently, many modalities are delivered in combination. Our client was interested to evaluate the efficacy and safety of a monoclonal antibody in combination with radiotherapy in patients with advanced NSCLC. In this project, we extracted data from around 100 studies based on the data extraction grid shared by the client.
    Therapy area: Oncology

  • Lung cancer: epidemiology, humanistic, economic, and clinical outcomes after specific therapies

    view case study

    Two main types of lung cancer are non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Both these types differ in terms of epidemiology, natural history, treatment, and prognosis. For a project, we helped our client in collating evidence on the epidemiology, humanistic and economic burden, treatment patterns, and clinical outcomes among patients with advanced stages of both NSCLC and SCLC without any specific mutations of interest, who had received at least one session of check-point inhibitor (CPI) therapy or platinum-based therapy as a part of another project. We identified relevant studies by performing data abstraction from over 3800 records over 2 levels of screening.
    Therapy area: Oncology

  • Pneumococcal conjugate vaccines: generating data on outcomes among special populations

    view case study

    For protection against disease caused by Streptococcus pneumoniae (pneumococcus), available vaccine options include polysaccharide vaccines (where pneumococcal capsular polysaccharides are used) and the more popular pneumococcal conjugate vaccines (PCVs, where pneumococcal antigens are conjugated onto another protein component to enhance antibody response). Two of the most popular PCVs are PCV7 and PCV13, which use antigens from 7 and 13 serotypes of pneumococcus respectively. Our client was interested to understand the clinical efficacy, real-world effectiveness, and impact of both these PCVs among children with otitis media, and among with children at a high risk of developing pneumococcal disease. For both these projects, we cumulatively examined over 2400 articles over 2 rounds of screening each, to identify a total of 75 full texts which contained the most relevant information that the client was interested in. We also performed data extraction from these 75 papers using the data extraction grid provided by the client.
    Therapy area: Infectious diseases, Vaccines

  • Alopecia areata: compiling data pertaining to various facets of the disease

    view case study

    Alopecia areata (AA) is a form of non-scarring hair loss that presents with patchy areas of alopecia. It usually affects the scalp, and is associated with significant loss of quality of life (QoL). Various treatment options are available for AA, including topical, intralesional, and systemic therapies. Our client was interested to generate current evidence surrounding the prevalence, treatment options, QoL, economic aspects, guidelines, and unmet needs of AA. For this project, we prepared the PubMed search strategy, performed data abstraction and selected the most appropriate studies from around 500 papers in two rounds of screening, and also performed data extraction from around 90 most relevant papers using the data extraction grid that we prepared based on client needs. As a follow-up to the same project, we identified articles containing information about etiology, risk factors, molecular pathogenesis pathway, and clinical signs of AA by screening through around 600 papers through two rounds of screening.
    Therapy area: Dermatology

  • Alpha-1 antitrypsin deficiency: compiling various facets of its natural history

    view case study

    Alpha-1 antitrypsin (AAT) is a glycoprotein produced by the liver hepatocytes (and in smaller quantities by other cells in the body), and is essential for the normal functioning of liver and lungs. Genetic absence of the protein, which is termed AAT deficiency, leads to uninhibited activity of the enzyme trypsin, causing extensive tissue breakdown; this can lead to complications in the lung (such as COPD) and liver (such as cirrhosis). Our client was interested to understand the natural history of AAT deficiency and its associated hepatic and pulmonary complications, especially surrounding prevalence, incidence, progression, diagnostic features, comorbidities, disease outcomes, and risk factors. For this project, we screened close to 3400 articles over two rounds of screening, and after identifying the 70 most relevant papers containing information that the client was looking for, we also extracted data following the data extraction grid shared by the client.
    Therapy area: Metabolic

  • Acute-on-Chronic Liver Failure: generating a consensus definition from multiple definitions

    view case study

    Acute-on-Chronic Liver Failure (ACLF) is a life-threatening medical condition with high mortality rates. The “Acute-on-Chronic” designation refers to patients’ clinical presentation of hepatic degeneration on top of pre-existing chronic liver disease. However, it has been felt that there is a lack of consensus surrounding the term ACLF, because there are multiple definitions for the term provided by multiple associations and organizations. Our client was interested to understand the similarities and differences across these ACLF definitions, and for this project we assisted our client by performing a comprehensive assessment of the definitions and extracting data pertaining to these definitions from 41 full texts based on the data extraction grid shared by the client.
    Therapy area: Gastroenterology

  • Ulcerative colitis: epidemiology; clinical, humanistic, and economic burden; and management options

    view case study

    Ulcerative colitis (UC) is an inflammatory disorder involving large intestine in which there is formation of inflammatory ulcers in colon and rectum, that is common in North America and Europe. Many treatment options are available, but definitive treatment of non-responding cases of UC generally require surgical management. Our client was interested to develop evidence surrounding epidemiology, clinical, humanistic, and economic burden, and management options of UC. For this project, we performed data abstraction of nearly 3000 articles over two rounds of screening and identified the articles with the most relevant information pertaining to the objectives of the targeted literature review, using criteria given by the client. We also extracted data from 83 studies based on the data extraction grid shared by the client.
    Therapy area: Gastrointestinal

  • Non-Hodgkin lymphoma: Generating evidence surrounding two rare subsets of the disease

    view case study

    Refractory follicular lymphoma (RFL) and marginal zone lymphoma (MZL) are two subsets of non-Hodgkin lymphomas affecting B cells. Both these types of lymphomas are rare conditions, and are often viewed as orphan diseases. For the same reason, despite contributing to a significant burden on the healthcare systems around the world, the evidence surrounding the epidemiology, clinical features, and management outcomes of these two conditions are far from complete. Our client was interested to understand the clinical, humanistic, and economic burden, treatment patterns, and epidemiology of RFL and MZL. For this project, we performed data extraction from 30 full texts and 16 study abstracts shared with us by the client, and populated the data extraction grid that was shared with us.
    Therapy area: Oncology

  • Menopause-related vasomotor symptoms: comparative efficacy of various treatment options

    view case study

    As a part of post-menopausal physiology, most women suffer from a menopause-related vasomotor symptoms (MR-VMS), including hot flashes and night sweats. While mild episodes of MR-VMS subside without treatment, moderate to severe episodes often require treatment. Most frequently prescribed therapy for MR-VMS is hormonal replacement therapy (HRT), while non-hormonal therapies are also available. Our client was interested to understand the efficacy of various available treatment modalities (HRT and non-HRT) for MR-VMS from published randomized controlled trials. For this project, we performed data abstraction of over 2700 articles over two rounds of screening and selected the most relevant papers containing the information of interest to the client. We also performed data extraction from 71 articles pertaining to clinical efficacy and patient-reported outcomes of various therapies.
    Therapy area: Endocrinology

  • Hepatic fibrosis: contribution to clinical, humanistic, and economic outcomes in different forms of hepatitis

    view case study

    Fibrosis of the liver occurs following healing of any injury to the liver, and there is replacement of healthy hepatic tissue with fibrous tissue or scar. Advanced stage of hepatic fibrosis is called cirrhosis, and is associated with significant morbidity and mortality. The important causes of hepatic fibrosis include viral hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis (NASH), biliary obstruction, autoimmune hepatitis, etc. Our client was interested to study the association between the stage of liver fibrosis and clinical, quality of life, and economic outcomes in Hepatitis B, Hepatitis C, and NASH through a targeted literature review. For this project, we extracted data from 38 studies identified by the client and shared the information in the prescribed format, which was used by the client to prepare a study report.
    Therapy area: Gastrointestinal, Hepatology

  • Hepatic fibrosis: generating evidence on multiple disease parameters

    view case study

    There are different options for the diagnosis and assessment of hepatic fibrosis: some are invasive, some are non-inavsive. Each has its own set of merits and demerits. Our client was interested in comparing the outcomes of using traditional histological assessment of liver fibrosis with non-invasive assessment options such as biomarkers and sonography. For this project, we extracted data from 24 articles based on the data extraction grid shared by the client.
    Therapy area: Gastrointestinal, Hepatology

  • Triple negative breast cancer (TNBC): efficacy and safety of available treatment options

    view case study

    Triple Negative Breast Cancer (TNBC) is a subtype of breast cancer that based on immunohistochemistry (IHC) is estrogen receptor (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2 (HER2) negative. Our client wanted to explore the efficacy and safety of available treatment options for managing TNBC. For this project, we abstracted around 3000 records through 2 levels of screening based on eligibility criteria shared by the client, and identified the most relevant articles for evidence synthesis.
    Therapy area: Oncology

  • Locally advanced breast cancer (LABC): efficacy and safety of 2nd line or later treatment options

    view case study

    Locally advanced breast cancer (LABC) is a subset of breast cancer characterized by the most advanced breast tumours in the absence of distant metastasis. Multimodality treatment involving surgery, chemotherapy, and radiotherapy in combination with hormonal and targeted therapy as required, can significantly improve outcomes in patients with LABC. Our client was interested in evaluating the efficacy and safety of 2nd line or later treatments of LABC. For this project, we abstracted around 1000 records through 2 levels of screening to identify the most relevant articles for evidence synthesis, and also extracted data from 14 studies.
    Therapy area: Oncology

  • Breast cancer among premenopausal women: efficacy and safety of available treatment options

    view case study

    Breast cancer among premenopausal women often presents at more advanced stages, and has less favourable prognosis than among postmenopausal women. Despite this, premenopausal breast cancer is an under-represented population in clinical trials. Our client was interested to understand the efficacy and safety of available treatment options for the management of advanced HR+, HER2- breast cancer among pre-menopausal women. For this project, we abstracted around 560 records through 2 levels of screening to identify the most relevant articles for evidence synthesis, and also extracted data from 5 studies.
    Therapy area: Oncology

  • Advanced breast cancer: clinical and patient reported outcomes

    view case study

    Breast cancer is among the most frequent cancers among women, and is associated with a considerable amount of clinical, humanistic, and economic burden. There are multiple forms and variants of breast cancer. Our client was interested to understand the patient-reported outcomes in addition to clinical efficacy and safety of all available treatment options for managing HER2+ or HER2+/HR+ breast cancer, especially in advanced, inoperable, or metastatic stages. For this project, we abstracted around 6000 records through 2 levels of screening to identify the most relevant articles for evidence synthesis, based on the eligibility criteria shared by the client. Therapy area: Oncology

  • Triple negative breast cancer (TNBC): humanistic burden

    view case study

    Triple-negative breast cancer (TNBC) accounts for 10-20% of all breast cancers. It is more commonly diagnosed in younger women and often has a less favourable prognosis compared with other breast cancer subtypes. Our client was interested to compile evidence on the humanistic burden of metastatic TNBC. For this project, we abstracted around 1000 records through 2 levels of screening to identify the most relevant articles for evidence synthesis, and also extracted data from 6 studies. Therapy area: Oncology

  • HER2+ breast cancer: epidemiology, humanistic, clinical, and economical burden

    view case study

    Human epidermal growth factor receptor 2 (HER2) is overexpressed in around 20–30% of breast cancer tumors: such cancers are often more aggressive, have higher recurrence rates, and are associated with an increased mortality. However, the availability of the HER2 receptor blocker trastuzumab to standard of care chemotherapy in clinical trials has improved outcomes for early stage as well as metastatic HER2 positive breast cancer. Our client was interested to understand the epidemiology, humanistic, economic, and clinical burden of HER2+ breast cancer. For this project, we searched and screened around 670 papers and conference abstracts to identify the most relevant records for evidence synthesis, based on eligibility criteria shared by the client.
    Therapy area: Oncology

  • Invasive pneumococcal disease: generating evidence on the impact of vaccination

    view case study

    Streptococcus pneumoniae, also known as pneumococcus, is a gram-positive bacterium that is the major cause of community-acquired pneumonia, and also causes other serious infections such as meningitis, sepsis, and a host of invasive pneumococcal infections including otitis, bronchitis, conjunctivitis, osteomyelitis, endocarditis and cellulitis, to name a few. Routine childhood vaccination through polyvalent pneumococcal vaccines (PCV-7 and PCV-13) to prevent pneumococcal infections are recommended by the WHO, but are not incorporated in all countries yet. Our client was interested in understanding the clinical efficacy of PCV-7 and PCV-13 among children with otitis media (OM), both in clinical trial and in real-world settings, and to explore how vaccine use impacted the incidence of OM among previously healthy children. For this project, we performed data abstraction and curation of more than 650 articles through two levels of screening and identified the most relevant papers for data extraction. For a different review, we helped our client to compile evidence on the immunogenicity and clinical efficacy of PCV-7 and PCV-13 among children at high-risk of developing pneumococcal infections, in both clinical trial and real-world settings, and the impact of vaccine use on the incidence of all-cause invasive pneumococcal disease in this population, by abstracting nearly 1750 articles through 2 levels of screening, identifying the most relevant papers for data extraction.
    Therapy area: Infectious diseases, Vaccines

  • Hemophilia A and hemophilia B: efficacy, safety, and patient reported outcomes of different therapeutic options

    view case study

    Hemophilias are a group of inherited disorders of blood clotting wherein the coagulation cascade following injury becomes abnormal due to low amounts of clotting factors such as factor VIII (hemophilia A), factor IX (hemophilia B), and so on. While current management largely involves replacing the missing clotting factors, non-factor therapies (such as monoclonal antibodies and RNA interfaces) and gene therapy are being studied as possible therapeutic options for these disorders. Our client was interested to compile evidence surrounding the efficacy, safety, and patient-reported outcomes of factor replacement therapies and various non-factor therapies (excluding plasma derivatives and supportive therapies) for both hemophilia A and hemophilia B, in terms of bleeding rates and other surrogate markers. For this project, we screened over 2550 articles concerning both the disorders over 2 rounds of screening, based on eligibility criteria shared by the client, and identified the most relevant articles for data extraction, quality assessment, and report preparation.
    Therapy area: Hematology

  • COVID-19: generating data surrounding economic burden

    view case study

    The COVID-19 pandemic has been the major healthcare crisis that the world has witnessed in the recent years. Along with healthcare crisis, the COVID-19 pandemic was also associated with huge economic burdens. Our client was interested to conduct a systematic literature review pertaining to studies reporting the economic burden of COVID-19. For this project, we performed data extraction from a total of 48 papers identified by the client, using the data extraction grid provided to us. The data we extracted was used by the client to prepare a comprehensive study report about the economic burden of COVID-19. For a different project, we also extracted data pertaining to economic burden of COVID-19 (including direct medical costs, direct non-medical costs, indirect costs, and healthcare-related utilities) from 28 studies identified by the client.
    Therapy area: Infectious diseases; COVID-19

  • Gastroparesis: epidemiology, humanistic and economic burden, and treatment efficacy

    view case study

    Gastroparesis is a chronic disorder characterised by delayed stomach emptying without a blockage, and presenting features include nausea, heartburn, vomiting, early satiety, and boating sensation. The condition is associated with loss of quality of life, patient suffering, and economic burden resulting from reduced productivity and absenteeism. Our client was interested to generate evidence surrounding epidemiology, humanistic and economic burden, and efficacy of available treatment options for gastroparesis. For this project, we performed data abstraction and curation of over 1600 potential articles through two levels of screening and selected the most relevant papers for data extraction.
    Therapy area: Gastrointestinal

  • Gastroparesis: comparing efficacy and patient-reported outcomes of two diagnostic modalities

    view case study

    Gastroparesis is a collection of symptoms of nausea and vomiting associated with bloating and early satiety plus or minus upper abdominal pain, caused by delayed gastric emptying in the absence of mechanical obstruction. Different modalities are available for the diagnosis of gastroparesis, including CT, MRI, gastric emptying studies, and scintigraphy. Our client wanted to compare two diagnostic modalities used in gastroparesis evaluation, namely GEBT (gastric emptying breath test) and scintigraphy, with respect to both diagnostic parameters and patient-reported outcomes. For this project we performed data abstraction and curation of over 1200 potential articles through two levels of screening and extracted data from 53 most relevant papers. We were also involved in the subsequent updating of this systematic review by screening through over 300 articles and extracting data from 15 new articles.
    Therapy area: Gastrointestinal

  • Chemotherapy-induced nausea and vomiting (CINV): epidemiology, economic and humanistic Burden, and treatment efficacy

    view case study

    Chemotherapy-induced nausea and vomiting (CINV) is a common and debilitating side effect of cancer treatment, that is associated with a loss of appetite, leading to reduced oral intake of food and water, which further worsens the patient’s health. While numerous antiemetic agents are available, CINV continues to be an unresolved adverse effect of chemotherapy for many patients. Our client was interested to evaluate the epidemiology, humanistic and economic burden, and efficacy of various available treatment options for CINV. For this project, we screened over 1000 articles through 2 levels of screening, based on the eligibility criteria as shared by the client, and identified the most relevant papers for data extraction.
    Therapy area: Oncology

  • Acute Kidney Injury (AKI): economic burden of prolonged AKI

    view case study

    Acute kidney injury (AKI) is a sudden decrease in renal function, and is common among hospitalized patients. Patients who develop AKI are at an increased risk of developing chronic kidney injury. ‘Prolonged AKI’ is a less studied variant of AKI, wherein the kidney injury lasts more than 3 days. Our client wanted to understand the economic burden of prolonged AKI, compared to AKI that resolves more quickly. For this project, we screened over 2750 articles through 2 levels of screening and identified 40 most relevant papers that suited the eligibility criteria as shared by the client. We also performed data extraction from these 40 papers, the contents of which was used by the client to develop a targeted literature review report.
    Therapy area: Renal

  • Advanced pancreatic cancer: generating evidence about efficacy and safety of available treatment options

    view case study

    Treatment options for advanced, metastatic, and ‘unresectable’ cancer of the exocrine pancreas are limited, and are often associated with poor treatment outcomes in terms of survival and quality of life. Our client wanted to generate evidence pertaining to efficacy and safety of various treatment options, including conventional chemotherapy and immunotherapy, with special emphasis on survival (overall, and progression-free), treatment outcomes (disease control rate, duration of response, overall response rate, and other parameters), and safety (adverse effects, rate of and discontinuation of medication). We performed 2 levels of article screening, and also performed data extraction and quality assessment from the eligible studies for this project using criteria shared by the client.
    Therapy area: Oncology

  • Acute myeloid leukemia (AML): health economics, resource use, and health utilities

    view case study

    Acute myeloid leukemia (AML) is a cancer involving myeloid blood cells in which rapidly proliferating cancerous cells interfere with various normal functions of the body, including normal blood production. As an acute cancer, the condition rapidly progresses, and is fatal within few months if left untreated. AML is associated with huge clinical, humanistic, and economic burden and loss of quality of life among patients and their caregivers. Our client was interested to compare the health economic implications of AML from the perspective of four countries – Canada, Sweden, France, and USA – with respect to health economics, resource use, and impact on health utilities. We performed data extraction from a total of 55 studies pertaining to economic evaluation and resource utilization, which was used by the client to generate a detailed study report.
    Therapy area: Oncology

  • Pemphigus: epidemiology, humanistic and economic burden, and efficacy of available treatment options

    view case study

    Pemphigus is a group of autoimmune disorders affecting the skin and mucous membrane that leads to blistering lesions of the affected region. Severe forms of pemphigus can result in opportunistic infections, which can lead to significant complications including death. Current treatment of pemphigus involves immune suppression through corticosteroids and other drugs, which are associated with their own complications. Our client was interested to develop an overview of the pemphigus market, including epidemiology, clinical, humanistic, and economic burden of the disease, and the merits and demerits of the existing treatment options. For this project, we assisted our client by performing data extraction of around 120 relevant papers shared with us by the client, which was used by the client to develop a document to support market access activity of a new drug being developed for pemphigus treatment.
    Therapy area: Dermatology

  • Relapsing multiple sclerosis: efficacy and safety of available treatment options

    view case study

    Disease-modifying therapy involving drugs such as glatiramer acetate, dimethyl fumarate, fingolimod, interferon-beta preparations, natalizumab, and mitoxantrone, is the mainstay of treatment of relapsing multiple sclerosis. Our client was interested to evaluate the safety and efficacy of different treatment options for relapsing multiple sclerosis. For this project, we performed data abstraction and curation through two levels of screening of over 2400 potential articles and selected the most relevant papers for data extraction. Therapy area: Neurology

  • Relapsing multiple sclerosis: efficacy and safety of available treatment options

    view case study

    Disease-modifying therapy involving drugs such as glatiramer acetate, dimethyl fumarate, fingolimod, interferon-beta preparations, natalizumab, and mitoxantrone, is the mainstay of treatment of relapsing multiple sclerosis. Our client was interested to evaluate the safety and efficacy of different treatment options for relapsing multiple sclerosis. For this project, we performed data abstraction and curation through two levels of screening of over 2400 potential articles and selected the most relevant papers for data extraction.
    Therapy area: Neurology

  • Secondary progressive multiple sclerosis: efficacy and safety of available treatment options

    view case study

    Secondary progressive multiple sclerosis is a variant of MS in which there is a gradual neurologic deterioration after an initial relapsing-remitting course. Superimposed relapses can sometimes be observed in the clinical course of this condition. Our client wanted to compile evidence surrounding the safety and efficacy of different treatment options for secondary progressive multiple sclerosis. For this project, we performed data abstraction and curation of around 750 articles through 2 rounds of screening for identifying the most relevant studies for evidence synthesis.
    Therapy area: Neurology

  • Post-operative Gastrointestinal Dysfunction: epidemiology, humanistic and economic burden, and treatment efficacy

    view case study

    Post-operative gastrointestinal dysfunction (POGD), also referred to as post-operative ileus, is a common condition seen immediately after surgery with complex and multifactorial pathology. The condition is associated with increased patient suffering and cost of care. Our client was interested to generate evidence surrounding epidemiology, humanistic and economic burden, and efficacy of available treatment options for POGD. We assisted our client in performing data abstraction and curation through two levels of screening of over 450 potential articles and selected the most relevant papers for data extraction. In a separate project concerning the same condition, we evaluated nearly 1000 papers for eligibility as per criteria shared by the client.
    Therapy area: Gastrointestinal

  • Advanced Endometrial cancer: efficacy and safety of available treatment options when used in the real-world setting

    view case study

    Advanced endometrial cancer is generally associated with poor prognosis due to lack of effective treatment options which can prolong survival and achieve significant disease control. Our client was interested to compile information pertaining to the epidemiological burden of advanced endometrial cancer, treatment guidelines for the condition, the efficacy and safety profile of available treatment options for the condition, and the real-world treatment patterns for the cancer. For this project, we performed data extraction from 23 records identified by the client as containing essential information for preparing a comprehensive report. We also critically assessed the methodological quality of 53 papers identified by the client using the appropriate tool. The information that we shared with the client was used to generate a report that would support preparation of a narrative value of a two-drug combination that was being developed for launch in few global markets.
    Therapy area: Oncology

  • Chronic insomnia: Efficacy and safety of available treatment options

    view case study

    Chronic insomnia is associated with several physical and mental consequences, which are further responsible for loss of productivity, absenteeism, and healthcare costs. While several drugs belonging to different pharmacological classes are available for management of the condition, all of these are associated with safety concerns. Our client was interested to generate evidence surrounding efficacy and safety of all available treatment option for chronic insomnia, which would be used to support market access activities surrounding a novel drug under development for the condition. For this project, we assisted our client with data abstraction and curation through which we identified the most relevant papers for data extraction, using the criteria shared with us by the client.
    Therapy area: Neurology

  • Moderate-to-severe plaque psoriasis: Efficacy and safety of available treatment options

    view case study

    Plaque psoriasis is a chronic, inflammatory, multi-system disease characterised by flaky, itchy, scaly skin and associated with numerous systemic complications. Effective medications for this condition include conventional drugs, and biologics, which are both more efficacious as well as more expensive. Our client was in the process of commercializing a new biologic for this condition, and wanted to generate evidence pertaining to the efficacy and safety of the existing treatment options for this condition by means of a systematic literature review and network meta-analysis. For this project, we assisted our client with data curation through two rounds of screening of all possibly relevant papers shared with us by the client, and identified the most relevant papers for data extraction and quality assessment, which was used by the client for HTA submission purposes.
    Therapy area: Dermatology

  • Varicella-associated systemic complications

    view case study

    Varicella (chicken pox) is a vaccine-preventable infectious condition caused due to infection by varicella zoster virus. Even though varicella symptoms are mild, systemic complications are often described with relation to varicella. Our client wanted to prepare a comprehensive compilation of complications due to varicella, with a special emphasis on duration, rate of occurrence, and symptoms. For this project, we assisted the client with data curation through which 130 eligible records were identified from an initial pool of over 2000 records. We also performed data extraction, and quality assessment of the included records, and also prepared a comprehensive study report of the entire systematic literature review.
    Therapy area: infectious diseases

  • Value of pressurized metered dose inhalers in COPD: updating the existing evidence

    view case study

    Selection of proper device for delivering inhalational drug for treating chronic obstructive pulmonary disease (COPD) is essential to ensure optimal treatment outcomes. Device selection, ease of use, familiarity, and availability are known to affect the disease progression, and even when a drug with proven efficacy is used with improper device, the disease is known to worsen. Our client wanted to update a previously prepared TLR surrounding the value of pressurised metered dose inhalers (pMDIs) in COPD and include patients with asthma as well. We updated the search strategy, screened around hits for the most relevant articles over two rounds, and extracted data from over 250 eligible papers, which helped the client to prepare a project report.
    Therapy area: Respiratory

  • Medication adherence of long-acting medications given as injectable or oral formulations

    view case study

    Long-acting medications often tend to have poor medication adherence rates, especially if the route of administration is not oral, because of poor patient satisfaction and treatment experience. The resulting poor medication adherence can lead to poor treatment outcomes and worsening of the disease. Our client was interested to explore the role of factors such as route of administration, dosing frequency, patient convenience, and patient satisfaction on adherence to certain long-acting medications on specific indications such as hyperlipidemia, osteoporosis, psoriasis, alcohol dependence, and schizophrenia. We screened around 3800 abstracts for identifying the most relevant sources of information, based on the eligibility criteria provided to us by the client.
    Therapy area: Metabolic, Orthopedics, Dermatology, Psychiatry, Substance abuse

  • Glycogen storage disease type II (Pompe’s disease): generating evidence on clinical, humanistic, and economic burden

    view case study

    Pompe disease is a subtype of glycogen storage disease (type II), in which there are mutations in the gene coding for acid alpha-glucosidase (GAA), the enzyme that breaks down glycogen in acidic milieu of the lysosome, resulting in a severe metabolic myopathy. Our client wanted to generate evidence surrounding the humanistic burden of GSD type II (Pompe disease), along with the clinical effectiveness and pharmacoeconomic considerations of enzyme replacement therapy for Pompe disease, which would be used for HTA submissions for NICE. For this project, we identified the most relevant papers for data extraction through two rounds of screening of nearly 2000 papers, using the criteria shared with us by the client.
    Therapy area: Metabolic

  • Delayed Graft Function (DGF) following kidney transplant

    view case study

    Delayed graft function (DGF) is a severe form of acute kidney injury resulting from an ischemia and reperfusion injury. It is a common complication following renal transplantation from a deceased donor. DGF is associated with a significant clinical and economic burden, and is a significant determinant of long-term success after renal transplantation. Our client was interested to systematically review the available literature concerning the clinical, humanistic, and economic burden of DGF following renal transplantation, specially in the last 15 years. For this study, we extracted data from 91 articles based on guidelines and data extraction grid shared with us by the client, the findings of which was used by the client to generate a detailed study report.
    Therapy area: Transplantation medicine, Renal

  • Chronic kidney disease (CKD): disease burden, epidemiology, treatment patterns, and guidelines

    view case study

    Chronic kidney disease (CKD), also called chronic kidney failure, describes the gradual loss of kidney function. Chronic kidney disease can progress to end-stage kidney failure, which is fatal without artificial filtering (dialysis) or a kidney transplant. Our client wanted to conduct a targeted literature review of burden of disease, epidemiology, treatment patterns, guidelines, and current trial designs and data on competitors on published SLRs and meta-analyses (MAs). A search strategy was developed using EMBASE Search Strategy (via OvidSP), Medline Search Strategy (via OvidSP), and subsequently identified the most relevant papers from around 3,800 articles over 2 rounds screening.
    Therapy area
    : Renal

MARKET ACCESS AND VALUE STORY DEVELOPMENT
  • Intravenous Iron Preparations: Polishing the Payer Value Proposition Slide Deck

    view case study

    Intravenous (IV) iron supplementation is the preferred treatment option for managing severe iron deficiency (ID) and ID anemia (IDA). Among the available IV iron preparations, ferric derisomaltose (FDI), ferric carboxymaltose (FCM), and iron sucrose (IS) stand out, each offering unique benefits and drawbacks. Our client had developed a draft value proposition for their IV iron preparation, intending to support global market access initiatives. They sought our expertise to refine and enhance the content and presentation of the slide deck. In this project, we helped our client to ensure the information in the value proposition slide deck was accurate, concise, and relevant. We also standardized the terminology and phrasing for consistency. We organized the slides logically to create a coherent narrative and provided uniform citation and referencing to enhance credibility. Additionally, we included clear definitions and explanations of essential health economic terms to ensure the deck serves as a comprehensive, stand-alone resource for market access activities. By these activities, we transformed the draft slide deck into a polished, professional, and effective tool for supporting the global market access efforts of our client. Therapy area: Hematology.

  • Type 2 Diabetes Market Research: GLP-1 Agonists and SGLT2 Inhibitors in Japanese Market

    view case study

    GLP-1 agonists such as exenatide, semaglutide, and tirzepatide, and SGLT2 inhibitors such as canagliflozin, dapagliflozin, and empagliflozin, represent frontline drugs for the management of type 2 diabetes mellitus (T2DM). With many new drugs being investigated worldwide in these two classes, market competition is quite intense in this space.

    Our client was interested in a secondary-only deep dive of the Japanese T2DM market landscape, with a special focus on GLP-1 agonists and DGLT-2 inhibitors. For this project, we prepared an extensive report consisting of T2DM guidelines in Japan, phase 1 to phase 3 assets in the GLP-1 and SGLT2i pipeline, analysis of key clinical trial timelines, estimation of potential launch timelines, market drivers, SWOT analysis of key competitors, and company profiles. The entire project was executed in three phases, consisting of literature review, landscape review, and trial timelines/ insights, and we provided insights into the Japanese T2DM market with comparison and contrasts to the US market. Therapy area: Metabolic, Diabetology.

  • Viral Hepatitis: Value of Diagnostics

    view case study

    Viral hepatitis, especially due to HBV and HCV, is a cause for major health care burden across the world, and also in India. With multiple genotypes, different modes of transmission, and possibilities for long-term sequalae, management of HBV and HCV hepatitis is a public health issue in India, as evidenced by the launch of National Viral Hepatitis Control Program (NVHCP) in India during 2018. Our client was interested to prepare a dossier discussing the value of different diagnostic tests in the management of viral hepatitis. For this project we performed in-depth research about the epidemiology, natural history, current diagnostic and treatment landscape, patient journey in India, available programs for hepatitis control, and health economics of hepatitis diagnosis. Backed with the above knowledge, we compiled the value of diagnostics in viral hepatitis management in India, and presented our findings in the form of a comprehensive dossier. Therapy area: Infectious diseases.

  • Market projection for the use of uroflowmetry and bladder diary among patients with moderate to severe lower urinary tract symptoms

    view case study

    Lower urinary tract symptoms (LUTS) affects both men and women, and is a sign of urinary tract obstruction due to various causes. Uroflowmetry and bladder diary are two modalities used in the evaluation of moderate to severe LUTS. Our client was interested to develop a model to forecast the number of patients with LUTS in the USA over the next five years, which would be used to predict the number of users of uroflowmetry and bladder diary over the time period. We developed a tool to cater to these requirements, and using the same, we developed a detailed report summarising the disease burden of LUTS in the USA, market size (present and future), pricing and reimbursement market analysis, and competitor landscape for both uroflowmetry and bladder diary, with a prediction in the number of urologists who may adopt these technologies in the next 5 years. This report was used by our client to prepare market access and pricing-reimbursement strategies.

  • Development of key performance indicators for value-based care of orthopaedic surgeries in hospitals

    view case study

    We assisted our client to develop certain key performance indicators (KPIs) which would help the client to objectively assess and quantify the quality of care provided to patients undergoing certain orthopaedic surgeries. Using the KPIs developed by us, the client would ‘score’ the quality of care by the hospital, and objectively assess the lacunae in order to rectify them. For this project, we developed the KPIs, and also provided the client with a framework to capture data for calculating the KPIs. The KPIs developed by us took into consideration both hospital-related parameters (such as duration of hospital stay, infection post-surgery, etc) as well as patient-related outcomes (such as pain, patient satisfaction, activity limitation, etc). Subsequently, we also analysed the KPIs and generated a comprehensive report which was used by the client for benchmarking the services provided by hospitals which practiced value-based healthcare delivery.

  • Expanding access & reimbursement in “Second Tier” markets in India

    view case study

    One of our clients wanted to understand the potential to expand access & reimbursement in “Second Tier” markets in India for a mature oncology biologic drug (not immuno-oncology), which is endorsed by international guidelines for 1L use in select cancers. We helped the client in explaining about the level of utilization and reimbursement of biologics in general in the specific markets (not necessarily in oncology), incl. compliance to international guidelines, recent and future landscape changes (including HC policy) that might have an impact on the oncology treatment landscape and specific market access and reimbursement challenges and opportunities relevant for oncology (tendering, level of formularies, budget caps) in India. The findings were shared in the form of a brief report.

  • Gain and understanding of carcinoma innovation specific market access landscape in China

    view case study

    Primary liver cancer encompasses Hepatocellular carcinoma (most common primary malignancy of the liver), Cholangiocarcinoma (<10%), and some other rare histologic types. Liver cancer is the 5th most common cancer and the 2nd most frequent cause of cancer-related deaths globally. Current treatment options for HCC are majorly dependent upon the tumor size and include surgical resection, liver transplantation, thermal ablation and chemoembolization. Our client wished to enter this therapeutic domain with an innovative product that uses LTSL (lysolipid thermally sensitive liposome) technology to encapsulate Doxorubicin, a proven and commonly used cancer drug. With the product, that was being evaluated in a global phase 3 clinical trial for the treatment of primary liver cancer, the client wanted to seek further clarity and understanding of the HTA scenario in China – considered to be as one of the most important markets for there product. We helped them by liasoning with China HTA experts and creating HTA landscape assessment report along with oncology specific information. We also provided case studies of products, which got successful market access in China in last decade.

  • Multiple Myeloma in Asian Countries

    view case study

    Multiple myeloma is a common hematologic malignancy that has been on rise in Asian countries. Our team aided a pharmaceutical client in generating evidence to demonstrate and support the value of a drug (a selective proteasome inhibitor) for the treatment of multiple myeloma in certain Asian nations. To strengthen the value story, we gathered relevant information through extensive literature search. Approximately 2384 studies were screened for 1st pass, 278 studies were screened for 2nd pass and data was abstracted from 56 studies. Additionally, we developed the value story of the pharmaceutical product of interest based on the data that characterized natural history of disease in the particular Asian locations, burden of illness in those regions, common patterns of care, unmet or under-addressed medical need and benefit-risk profile of the desired pharmaceutical agent

REAL WORLD EVIDENCE/ EHR SERVICES
  • Multiple Myeloma: Utilization Pattern of a Chemotherapy Drug in the USA

    view case study

    Multiple myeloma, also known as plasma cell myeloma, is a cancer involving plasma cells, and can present with varying symptoms. Management involves chemotherapy targeting malignant cells, and is usually followed by stem cell transplant. Our client was interested to understand the utilization of a specific drug used in the chemotherapy of multiple myeloma in the US health care system. For this study, we abstracted around 95 elements per patient from EHRs into e-CRFs provided to us by the client, over a period of 4 months, and completed the project with over 97% accuracy. Therapy area: Hematology, Oncology.

  • Non-Small Cell Lung Cancer: Utilization Pattern of a Chemotherapy Drug in the USA

    view case study

    Non-Small Cell Lung Cancer (NSCLC) accounts for over 85% of all lung cancers, and is a type of epithelial cell cancer that is often associated with a poor treatment outcome and high mortality. Treatment options for NSCLC include surgery, radiofrequency ablation, radiation therapy, chemotherapy, and immunotherapy. Our client was interested to understand the utilization of a specific drug used in the chemotherapy of NSCLC in the US health care system. For this study, we abstracted around 35 elements per patient from EHRs into e-CRFs provided to us by the client, over a period of 6 months, and completed the project with over 98% accuracy. Therapy area: Oncology.

  • HER2+ Breast Cancer: Utilization Pattern of an Immunotherapy Drug in the USA

    view case study

    HER2 receptor amplification or overexpression is seen in around 20-30% of breast cancer patients. Though untreated HER2 +ve breast cancers have a more aggressive course than HER2 -ve breast cancers, HER2 +ve breast cancers can be treated with immunotherapy agents that target the HER2 receptor, and because of this the prognosis is often better. Our client was interested to understand the utilization of a specific drug used in the immunotherapy of HER2+ breast cancers in the US health care system. For this study, we abstracted around 80 elements per patient from EHRs into e-CRFs provided to us by the client, over a period of 12 months, and completed the project with over 98% accuracy. Therapy area: Oncology.

  • Severe Asthma: Training a Machine Learning Model for EHR Abstraction using NLP

    view case study

    Asthma that is not adequately controlled by approved drugs, or those controlled cases which recur after treatment is reduced, is termed severe asthma. It is estimated that 5-10% of asthma patients suffer from severe asthma. Our client was interested in training a machine learning (ML) model for EHR abstraction using natural language processing (NLP), with an intention to generate insights in support of a particular drug for severe asthma support. For this project, we generated NLP-based automated annotations, analyzed false positives and false negatives with extracted concepts, and trained the ML algorithm until a precision of 90% was met. The end result provided the insights which were in line with the study objective. The evidence synthesized using these inputs gave the clients a quick access to information about different use patterns of the drug of interest in the patient cohort. Therapy area: Respiratory

HEOR AND MODELLING PROJECTS
  • Validating the inputs and calculations in a cost effectiveness model and developing one-way sensitivity analysis calculations

    view case study

    Among various blood glucose monitoring options in diabetes mellitus (DM), a continuous glucose monitor (CGM) stands out by virtue of providing continuous blood glucose trends, which is missed by traditional intermittent blood glucose monitoring. Usage of CGM devices have also been associated with a reduced time spent in hypoglycemia, lower number of severe hypoglycemia events (SHE), fewer episodes of DM-related complications such as diabetic ketoacidosis (DKA), and overall lower values of glycated haemoglobin (HbA1c). However, since the CGM device represents an additional investment, establishing the cost effectiveness of the device is essential.

    Our client had developed a basic cost savings model for a CGM device keeping in mind two possible scenarios of clinical outcomes in terms of SHE, DKA, and HaA1c. We validated the inputs and calculations in this model, updated the entire model in terms of the general usability and look-and-feel, and also developed a one-way sensitivity analysis (OWSA) into the model, thereby improving the robustness of the model. Therapy area: Metabolic, Endocrinology.

  • Budget Impact modelling of a drug/ device combination for the treatment of pancreatic cancer

    view case study

    Novel treatment modalities are being developed for treating pancreatic cancer, which has as such a poor prognosis. One such novel modality involved a combination of a chemotherapy drug with a novel drug delivery system through a specially designed catheter. Our client was interested to understand the budget impact and impact on reimbursement of different pricing strategies for the combination, which was granted orphan drug status by the USFDA. We developed a detailed budget impact modelling analysis dissecting the value proposition, reasoning, and risks associated with different price corridor for the combination, for targeting the US market. For doing this, we considered multiple perspectives (insurer, manufacturer, and hospital) and determined the best possible pricing strategy for the manufacturer with best ICER, based on evidence from previous studies, competitor pricing, and current and future reimbursement scenario in the US.

  • Cost of Stigma Associated with HIV: A Cost-consequence Analysis

    view case study

    Stigmas associated with HIV in Saudi Arabia have resulted in an increased clinical, humanistic, and economic burden on the country’s healthcare resources. Interventions such as prevention of mother to child transmission (PMTCT) and HIV self-testing (HIVST) might address some of these stigmas and increase diagnosis and treatment of HIV. Client developed a health economic model (Markov model) to estimate the cost-effectiveness of stigma-addressing interventions to improve diagnosis and treatment of HIV from a societal perspective in a KSA setting, using data from various external sources. The stigmas related to having unprotected sex, testing for HIV infection as a member of a risk group, and seeking treatment if infected, were included in the model. It was found out in the research that both PMTCT and HIVST are costing saving stigma-addressing interventions for PLHIV in KSA. We helped the client in manuscript preparation for the purpose of publication.

  • Clinical, humanistic and economic burden of NAFLD and NASH

    view case study

    The prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) is high in the Middle East; however, there are no approved therapies currently available for these conditions. The client developed a health economic model (Markov model) to estimate the current and future clinical, economic and humanistic burden of NAFLD/ NASH in KSA, UAE, and Kuwait, from a societal perspective. Model input data was obtained from population projections from previous studies and UN data. Transition probabilities were calculated after extracting data from similar studies in the past using a graph digitization software. Country-specific costs incurred in the treatment of NAFLD (including medication, medical management, and healthcare procedures) and utility inputs were obtained from local experts. The costs, QALYs and LYs associated with each health state were calculated for all three countries. It was found out that NAFLD/ NASH is associated with substantial clinical, economic, and humanistic burden in the KSA, UAE and Kuwait. We helped the client in creating manuscript from the model report provided to us.

  • Clinical, economic and humanistic burden of treatment resistant depression

    view case study

    We helped our client to conduct the targeted literature review/secondary literature search to capture information related to Treatment Resistant Depression (TRD) for GCC region (KSA, UAE & Kuwait) and Emerging Markets (Egypt, Algeria, Lebanon & Turkey). We further helped them to build a universal economic model from scratch to assess the over all economic burden (considering direct and indirect cost) of TRD from payers’ and societal perspective and assisted in developing questionnaire for expert interviews to address the gaps identified in the literature search and to populate/validate the model/(s). The model was adapted by populating it with local data specific for each country. The outcome findings were consolidated in the form of white paper and manuscript.

  • Cost effectiveness analysis of accelerated transition from oncological treatment to specialised palliative care at home

    view case study

    While hospitals remain the most common place of death in many western countries, specialised palliative care (SPC) at home is an alternative option to improve the quality of life in their final days of life. This manuscript is a full economic evaluation (Cost-utility analysis) of an accelerated transition to home for incurable cancer patients in need of palliative care. The analysis is performed from a societal perspective within a randomised controlled trial – the Danish Palliative Care Trial (DOMUS). The researchers looked outcome in the form of incremental cost-effectiveness ratio (ICER) and found out that accelerated specialised palliative care and psychological treatment yields better QALYs than usual care with a large increase in costs. Based on usual willingness-to-pay thresholds, the intervention is not found to be cost-effective relative to usual care. We helped the client in manuscript editing and making it publication ready.

  • Comparing the cost effectiveness of two anticoagulants for the treatment of VTE

    view case study

    Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). Treatment primarily aims at preventing pulmonary embolism (PE), reduce morbidity, and minimize the risk of post-thrombotic syndrome. So far the mainstay of medical therapy has been anticoagulation. A pharmaceutical company wanted to compare the cost-effectiveness of two anticoagulant drugs used for the treatment and prevention of VTE. The source document and the manuscript outline were provided to us and we assisted our client with drafting the manuscript. The abstract of the manuscript was presented at a conference.

  • Report on the cost of cancer treatment and available options in India

    view case study

    In India, the average cost of cancer treatment ranges from Rs. 2.5 L to Rs. 20 L for six months leading the families into huge economic burden. On the demand of one of our clients,, the information was gathered on the sources of funding for cancer; the services availability in hospitals and clinics; government and non-government schemes for cancer; the process of incentivizing the healthcare providers; the role of drug manufacturer, wholesalers, distributors and providers in drug costing; and reimbursement strategy for cancer treatment in India. It also reports on the complications Indians are facing during cancer treatment.

ORIGINAL RESEARCH
  • Dyspepsia: Real-world evidence on demographics and treatment patterns in India

    view case study

    Dyspepsia includes a spectrum of symptoms ranging from epigastric pain, early satiety to post-prandial fullness. Precise prevalence of Dyspepsia in India is not available, and available evidence indicates that it affects 7.6-49% of Indian population. Through the analysis of a cross-sectional study involving nearly 3750 dyspepsia patients across India in the real-world setting, we found out that dyspepsia is more prevalent in males and in the 31-50 age group; functional Dyspepsia is more common than organic dyspepsia; and patients receiving rabeprazole had higher levels of medication adherence, higher satisfaction levels in symptom relief, better convenience of therapy, and higher perception of safety compared to patients on other PPIs. Therapy area: Gastrointestinal.

  • Blood Safety: Importance of nucleic acid testing (NAT) to detect infections in serononreactive blood donations

    view case study

    Serology is used routinely in all blood banks to identify several transfusion-transmitted infections (TTIs) including HIV, HBV, and HCV. But at times serology can be negative in blood donations that harbor these infections, for a variety of reasons. Nucleic acid testing (NAT) for viral genetic material is capable of identifying these infections undetectable by serology, thereby improving blood safety. The two forms of NAT, the minipool (MP)-NAT and the individual donor (ID)-NAT have their own merits and demerits. Our client wanted to assess the sensitivity and benefits of MP-NAT in a blood bank, through a retrospective data analysis. For this project, we performed data analysis, wrote a publishable manuscript out of the analysis, and also managed the publication by answering questions raised by the peer reviewers. Therapy area: Transfusion medicine.

  • Generating country-specific and instrument-specific reference intervals for thyroid function tests

    view case study

    Accurate identification of the changes in serum levels of thyroid-stimulating hormone (TSH) and free thyroxine (fT4) are crucial for the diagnosis of thyroid disorders. Given the sensitive nature of TSH and fT4 levels, it is essential that the appropriate reference intervals (RIs) are established adequately, and are accurate for the population and the assay technique. Our client wanted to establish RIs for TSH and fT4 specific for the Indian population, using TSH and fT4 values among clinically euthyroid non-smoking adult population, following CLSI criteria. For this project we performed complete statistical analysis including outlier identification through Tukey’s test and establishing the RIs based on the 2.5th and 97.5th percentile values. We also derived RIs for different subgroups, including males, females, age ≥30 years, and age >30 years and performed a comparison of values between these subgroups as well. Finally we drafted the results into a publishable manuscript.

  • Impact of nucleic acid testing (NAT) on Transfusion Transmitted Infections (TTIs)

    view case study

    Transfusion-transmitted infections (TTIs) are one of the biggest fears to blood transfusion safety. Nucleic acid testing (NAT) in blood donor screening has been implemented in many countries to reduce the risk of TTIs. Our client’s objective of this observational study was to assess the ability of NAT to detect hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) from donor blood samples declared seronegative. Every donor blood sample was screened for HBsAg, anti-HCVnti-HIV-1, anti-HIV-2 and p24 antigen by electrochemiluminescence assay. All initial serology non-reactive samples were subjected to NAT discriminatory assay for HBV, HCV and HIV. It was found out that the routine utilization of MP-NAT testing for HBV, HCV and HIV-1 has the potential to improve the efficacy of screening for protecting blood recipient from TTIs. It enables detection of these viruses, which were undetected by serological test and thus helping in providing safe blood to the patients. We assisted the client in preparing the manuscript for the purpose of publication.

  • A cytogenetic study of down’s syndrome in Iraqi population

    view case study

    Down’s syndrome is the most common type of chromosomal abnormality found in neonates. It is associated with characteristic abnormal facial features and mental retardation. However, clinical diagnosis is not sufficient to confirm the disease. Classical karyotyping has long been used as diagnostic tool for confirming Down’s syndrome. Our client conducted a study to confirm the cytogenetic composition of individuals suspected with Down’s syndrome after the preliminary clinical diagnosis in Basra, Iraq. We helped the client in manuscript preparation, which is due for publication. Study provided the basic information required to forecast the various complications associated with Down’s syndrome.

  • A human EGFR2 over-expression by immuno-histochemistry in patients with gastric adenocarcinoma

    view case study

    Gastric cancer is one of the leading causes of cancer-related deaths across the world and in the Middle East. Human Epidermal Growth Factor Receptor 2 (HER2) overexpression has been observed in gastric cancers. Trastuzumab, a recombinant monoclonal antibody targeting HER2 protein, is now being used for treatment of metastatic gastric cancer. Our client wanted to study the frequency and association of HER2 overexpression with age, gender, histopathological subtype and grade of differentiation in patients with gastric adenocarcinoma. It was a cross-sectional single-centre study. Demographic (age, gender), histopathological (histological subtype, grade of differentiation) and immunohistochemical (HER2 overexpression status) data from 100 consenting adult patients (male: 56) with histopathologically confirmed gastric adenocarcinoma from samples obtained through endoscopy or surgery was collected. We helped the client in preparing the manuscript. It was found that HER2 over-expression was 6% in the population; statistically significant correlation was found with histological grade. Manuscript is still under peer-review.

  • Combined effect of two anti-hyperglycemic agents in diabetes management

    view case study

    Diabetes affects a major proportion of the Indian population. Single anti-diabetic agents are not always effective in controlling this condition. Our client wanted to determine the combined effectiveness of two anti-hyperglycemic agents with complementary mechanisms of action in managing diabetes. An open, prospective, multicenter, single-arm, non-interventional study was conducted across several sites in India. The study was registered under the ClinicalTrials.gov and the Clinical Trial Registry of India. Postprandial glucose, fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c) levels were measured to determine the clinical effectiveness of the drugs. This study found that the combination of the two anti-hyperglycemic agents was well tolerated, safe and efficacious in Indian patients and could be considered a treatment option for diabetes management.

  • Prevalence and consequences of vitamin D deficiency in patients with chronic low back pain

    view case study

    Vitamin D deficiency has often been linked to chronic low back pain (CLBP). In many patients, vitamin D deficiency remains undiagnosed therefore untreated leading to persistent, musculoskeletal pain as observed in CLBP. So far no prospective studies have focused on the prevalence of vitamin D deficiency in Indian patients with CLBP. The client wanted to determine the prevalence of vitamin D deficiency in Indian patients and its role in CLBP. Data were obtained from a controlled, open label, single arm clinical trial that assessed the effectiveness of vitamin D supplementation in patients with CLBP. The study was conducted in an outpatient pain clinic of a tertiary care hospital. The findings were reported in accordance with the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) guidelines. Pain and functional disability was determined. Chi-square test and independent t-test was used for the categorical and continuous variables, respectively. Multivariate logistic regression model, univariate analysis of variance (ANOVA) and post hoc Bonferroni test was also used for statistical analysis. The study revealed increased prevalence of vitamin D deficiency among Indian patients with CLBP and indicated the importance of determining the vitamin D status for effective management of CLBP.

  • Efficacy, safety and tolerability of a preservative-free NSAID ophthalmic solution

    view case study

    Topical non-steroidal anti-inflammatory drugs (NSAIDs) are a preferred over topical steroids to control inflammation post cataract surgery and a preservative-free variation is considered the most effective. While the clinical effectiveness of the preservative-free NSAID in reducing cystoid macular edema (CME) and macular thickening in patients with cataract surgery is well established across many countries, its safety and efficacy was not studied in Indian patients. The client wanted to evaluate the safety, tolerability and efficacy of the preservative-free NSAID in controlling inflammation in Indian patients who were subjected to cataract surgery. A retrospective, open-labeled, single-arm study was conducted and data was obtained from the records of 96 cataract patients. The results confirmed that the preservative-free NSAID successfully reduced ocular inflammation and was well-tolerated in patients after cataract surgery.

  • Early initiation and goal directed enteral nutrition for effective ICU management

    view case study

    Early Nutritional Support is considered important for ICU management. Previous observational studies have indicated adverse clinical outcomes as a consequence of cumulative calorie debt. Our client hypothesized that early and goal directed enteral nutrition (EN) support to meet the calorie debt could lead to better outcomes. A retrospective observational study was conducted at a multidisciplinary ICU in a tertiary health care facility in India. The data obtained indicated that early initiation and goal directed EN could improve clinical outcome and thus aid in effective ICU management.

  • Efficacy and safety of supplemented low protein diet in patients with diabetic nephropathy

    view case study

    Diabetic nephropathy can lead to end stage renal disease (ESRD). Patients with chronic kidney diseases are put on low protein and very low protein diets to improve associated metabolic disorders and uremic symptoms. However, it is important to ensure that the diet fulfills the essential amino acid and energy requirements of the patients. Our client wanted to determine the efficacy and safety of low protein diet supplemented with keto-analogues of essential amino acids and its superiority over low protein diet without such supplementation. A randomized control trial was conducted at a reputed hospital in Mumbai and a total of 48 patients with diabetic nephropathy were included in this study. The demographic features, post-treatment survival probability etc. were studied. The results suggested the clinical effectiveness of supplemented low protein diet in delaying kidney complications that leads to ESRD. Additionally, the supplemented diet was found to be safe, improve metabolic conditions, and met the nutritional requirement of the patients.

  • Human Anti-Chimeric Antibodies (HACA) seen with a biologic drug is associated with higher BASDAI in axial spondyloarthritis patients

    view case study

    Treatment with chimeric mAb often results in the formation of human anti-chimeric antibodies (HACA) that may worsen the condition in axial spondyloarthritis (AS) and rheumatoid arthritis (RA) patients. In this case, our client’s KOL wanted to investigate the effect of infliximab therapy on both AS and RA patients. We did the data analysis and manuscript writing for the client. It was found that HACA was formed in AS patients treated with infliximab, but not in RA patients following same treatment. HACA-positive AS patients treated with chimeric mAb showed a higher post-treatment disease activity as measured by BASDAI and were associated with lesser post-treatment reduction in BASDAI than HACA-negative patients.

CLINICAL REVIEWS
  • Dry eye disease: role of flourescein staining for differential diagnosis

    view case study

    Dry eye disease (DED) is a multifactorial disease of the ocular surface that occurs due to loss of tear film homeostasis, and has multiple etiologies and subtypes. Fluorescein staining is a widely used diagnostic modality in the evaluation of various ophthalmological conditions affecting the corneal surface, including various etiologies leading to DED. With a historical use dating back to over 150 years, fluorescein staining has stood the test of time and continues to be a popular vital dye that does not require any specialized equipment other than slit lamp biomicroscope. Our client wanted a comprehensive review of the role of fluorescein staining in DED differential diagnosis. For this narrative review, we started with an overview of DED, reviewed the practical aspects of fluorescein staining, evaluated the place of fluorescein staining in modern ophthalmological practice, and included a visual atlas of fluorescein staining picture of ocular surface of common ophthalmological conditions. Therapy area: Ophthalmology.

  • Milk intolerance and milk allergy in infants and the role of modified infant formulas

    view case study

    Milk intolerance and milk allergy are two different conditions that are often used interchangeably, albeit erroneously. Milk intolerance arises due to deficiency of lactase enzyme, whereas milk allergy is an immunologically mediated condition. Our client wanted a comprehensive narrative review surrounding these two topics, which also touched upon alternatives to cow’s milk, recommendations from reputed bodies regarding use of these alternatives, and the role of modified infant formulas for infants who need milk supplementation but are having milk intolerance and/ or milk allergy. At the end of the review, we found out that though most guidelines recommend milk alternatives such as extensively hydrolyzed milk formula and amino-acid based formula, they suffer from palatability and cost. On the other hand, modified goat’s milk-based formula likely has nutritional profile and growth outcomes among infants that is comparable with cow’s milk. Therapy area: Nutrition and Dietetics.

  • The role of dydrogesterone in the management of threatened miscarriage and recurrent miscarriage

    view case study

    Threatened miscarriage and recurrent miscarriage are two frequent complications of pregnancy, which have been associated with lower levels of progesterone in circulation. Our client wanted a thorough review about the role of different types of progesterones in the management of these two conditions, with a special emphasis on dydrogesterone. Our literature review found out that dydrogesterone, a retroprogesterone that is produced from a natural source, has favourable pharmacokinetic profile, is well tolerated and has a favourable safety profile in all approved indications. It is safe in pregnancy, and is not associated with any adverse maternal or foetal outcomes attributable to teratogenicity. The efficacy, safety, and tolerability profiles of dydrogesterone have been extensively investigated, with favourable results in numerous large-scale RCTs and meta-analyses. Therapy area: Obstetrics and Gynaecology.

  • Bone turnover markers as a reference tool in therapeutic monitoring of bone pathologies

    view case study

    Bone turnover markers (BTMs) are key tools in monitoring the effect of anti-resorptive and anabolic therapies against bone pathologies. These tools assist in the management of osteoporosis therapy and predict the associated risks such as, the elevated bone turnover rate could indicate the bone pathologies. International Federation of Clinical Chemistry and International Osteoporosis Foundation have proposed serum C-telopeptide cross-links of type I collagen (CTX-1) and procollagen type 1 amino-terminal propeptide (P1NP) to be used as reference markers for bone resorption and bone formation, respectively. The BTM outcomes could be affected by the uncontrollable factors such as age, gender, pregnancy, menstruation, excess or under mobility, recent fracture, co-morbidities, and medications. We did a thorough literature search to bring the review on the above mentioned topic. We found out that the assessment of BTMs is crucial in elderly patients when adherence with and persistence to the therapy is essential to increase the efficacy of drugs. The advancement of BTMs in clinical and research settings of bone metabolic diseases treated with anti-resorptive and anabolic therapies were described in this review. Therapy area: Rheumatology.

  • Current scenario and the future trend of diabetes management in India

    view case study

    India ranks as one of the highest contributors to the global diabetes mellitus (DM) pandemic, with 65 million people i.e. 17% of global 382 million diabetics, residing in India. Diabetes imposes serious threat on overall health status of an individual and can be a risk in itself for multiple chronic and life-threatening diseases such as myocardial infarction, stroke, metabolic syndrome etc. Despite the growing concern regarding DM and its socioeconomic burden, diabetes control in India is far behind what is ideally expected. The mean hemoglobin A1c of diagnosed population is 9.0% – at least 2.0% higher than what is suggested by international bodies. The main objective of this article was to understand the scenario of diabetes in India with respect to its prevalence rate and future disease burden. Our client further aimed to determine the status of diabetes care and management in terms of available facilities, point of care, cost of treatment, various points of intervention and involvement of the non-governmental organizations. They further assessed the awareness level, screening and treatment initiatives for DM within the country with a focus on programs conducted by government bodies and finally reviewed the financial aspect in terms of source of funding and proportion of patients who can afford the treatment. We helped in creating this very interesting white paper for the purpose of publication, out of the information provided to us in the form of power point presentation. Therapy area: Metabolic, Diabetology.

  • A review on vitamin D deficiency associated complications

    view case study

    Vitamin D deficiency is a common occurrence and has been linked to several medical conditions including rickets in children to osteoporosis in adults. It also contributes to diabetes, metabolic disorders and cardiovascular disease. Our client wanted to review the pathophysiology of vitamin D deficiency and the associated clinical complications. A detailed review indicated the requirement for novel guidelines on Vitamin D supplementation to achieve better treatment outcomes, improve morbidity and patient health. Therapy area: Metabolic.

  • Role of superoxide dismutase in ameliorating reactive oxygen species related toxicity

    view case study

    Toxic reactive oxygen species (ROS), such as hydrogen peroxide, organic hydro peroxides, nitric oxide, superoxide and hydroxyl radicals etc. are constantly produced under physiological conditions and results in oxidative stress. The resultant imbalance in pro-oxidant/antioxidant homeostasis is responsible for the pathogenesis of different diseases. Our client wanted to obtain clinical evidence from global studies on the critical role of ROS in deteriorating human health and the importance of superoxide dismutase (SOD) in ameliorating the ROS toxicity. Electronic databases (Medline, Pubmed) were searched to identify relevant studies (peer reviewed case studies, observational studies, case control and cohort studies). Extensive data suggested the major role of ROS in the causation of several diseases. It also indicated that in order to maintain defense against ROS, SOD as an exogenous source would be necessary for anti-oxidative defenses.

  • Diabetic foot: A major complication of long-term diabetes

    view case study

    Diabetic individuals are at increased risk of peripheral arterial disease and neuropathy. Long-term diabetes can cause nerve damage and poor blood flow leading to diabetic foot (DF). It is a major complication that increases the risk of infection, gangrene and amputation in affected individuals. Our client wanted to review the recent advances and evidences that could improve DF management. Medline and PubMed were searched for relevant information (peer reviewed case studies, observational studies, case control and cohort studies) on DF as a major complication of diabetes. Data obtained indicated major gaps in novel approaches for DF prevention. It was concluded that appropriate awareness regarding diabetes related foot complications, importance of footwear and regular checkups can help to reduce diabetes related DF. Therapy area: Metabolic, Diabetology.

  • An overview of polycystic ovarian syndrome

    view case study

    Polycystic ovary syndrome (PCOS) is a common endocrine disorder among women of reproductive age. Our client wanted to summarize the underlying causes and common symptoms of PCOS and suggest suitable guidelines for effective management. It was evident that successful treatment of PCOS required proper diagnosis. Therapy mostly depended on the symptoms, age and future pregnancy plans. It was concluded that with accurate diagnosis, appropriate lifestyle interventions, and suitable PCOS treatment (birth control pills to regulate menstruation and insulin-sensitizing or androgen-blocking medications), this medical condition and the associated overwhelming health problems can be controlled. Therapy area: Endocrinology.

  • Literature review for better understanding of an uncommon variant of osteosarcoma

    view case study

    Telangiectatic osteosarcoma (TO) is an uncommon variant of an intramedullary high grade osteosarcoma that accounts for 2.5-12% of all osteosarcomas. There is limited understanding regarding the incidence, clinical presentation, treatment, and prognosis of this medical condition. The client wanted to systematically study the available literature to obtain detailed information on this high grade osteosarcoma. Literature review revealed poor prognosis of TO patients in earlier studies, however, recent use of neoadjuvant chemotherapy with surgery was reported to improve survival rates of the patients. The finding of this study corroborates the importance of early diagnosis and optimal treatment for improved outcomes. Therapy area: Oncology.

  • Hospitalization due to heart failure with dipeptidyl peptidase-4 inhibitor

    view case study

    The hypoglycemic efficacy of dipeptidyl peptidase-4 inhibitor has been demonstrated as monotherapy or in combination of other anti-hyperglycemic drugs. The SAVOR-TIMI 53 trial have raised the concerns about the increased risk of hospitalization due to heart failure following this particular dipeptidyl peptidase-4 inhibitor administration. As per the demand of our clients, all the relevant research articles along with reviews and other data was systematically reviewed. This systematic study showed that increase in hospitalizations due to heart failure have not been demonstrated by other trials as well as by real-world data analyses from insurance claims data involving a huge number of patients. The vast available evidences favour the clinical usage and safety of this dipeptidyl peptidase-4 inhibitor in various clinical conditions. Therapy area: Metabolic, Diabetology.

  • Indirect treatment comparison for biosimilars

    view case study

    Biosimilar is a biologic drug that is structurally and functionally similar to an original drug molecule of biological origin that has already been authorized for use. Generation of evidences for comparing a biosimilar with original biomolecule using direct head-to-head randomized controlled trials can be expensive, time-consuming and laborious. The client wanted a review about the indirect treatment comparison (ITC) for biosimilar that would provide useful evidence for judiciously selecting the best choice of treatment. A well-designed and appropriately conducted ITCs, being increasingly used for biosimilar approval in the EU, can be a valid alternative and means for efficacy and safety evidence generation.

COMPETITIVE INTELLIGENCE
  • Companion Diagnostics: Competitive Intelligence to Support Access and Evidence Generation 

    view case study

    Companion diagnostics (CDx) are tools in the precision medicine landscape that are used in identifying patients most likely to benefit from specific therapies enabling targeted treatment. Our clients sought to target competitive intelligence exercise to understand adoption challenges, access pathways, evidence requirements and competitive positioning of these tools. We conducted data extraction from commercial and global databases for Asian countries. We generated our findings in a structure report to support internal evidence planning and access strategy development across multiple geographies. 

    Therapy area: Companion Diagnostics 

  • Biologics: Competitive Intelligence for Biologic Manufacturers in Asia 

    view case study

    Biologics are large and complex molecules derived from living cells and are increasingly becoming a component of modern medicine with expanding pipelines and posing global competition. To support strategic planning, our client sought to gain competitive intelligence insights on biologic manufacturers across Asian countries. We conducted the data extraction using commercial websites and global databases not limited to FDA, EMA and WIPO, focusing on patents, clinical developments, regulatory approvals and manufacturing licenses to generate evidence on global market understanding and pipeline assessment. 

    Therapy area: Biologics 

CASE SERIES
  • Clinical efficacy of a tumor necrosis factor-α inhibitor in managing inflammatory polyarthritis in a patient with autoimmune inner-ear disease

    view case study

    Autoimmune inner-ear disease (AIED) is a rare autoimmune disorder characterized by progressive hearing loss. Of the several medical therapies proposed for the treatment of AIED, corticosteroid therapy is considered the most effective. Commonly tumor necrosis factor-α inhibitors are administered in combination with corticosteroids for favorable outcomes. The client examined the use of a popular anti-TNF drug in an AIED patient who developed inflammatory polyarthritis (IPA) and was non-responsive to therapy with steroids. The findings confirmed that the anti-TNF agent was successful in managing IPA in the patient with AIED.

  • Role of novel TNF-α inhibitor in the treatment of Hidradenitis Suppurativa: A study of two cases

    view case study

    Hidradenitis suppurativa (HS), also known as acne inversa, is a rare and long-term skin inflammatory condition diagnosed by small and painful swollen lumps, typically affecting the armpits, the groin, area between the buttocks, and under the breast. The unresponsive routine multiple treatment modalities necessitated a more efficacious treatment for HS. On demand of our clients, the effect of a novel TNF-α inhibitor was studied on two adult patients who were severely affected by HS (Hurley stage III). These two cases were the first of its kind demonstrating the success of this particular TNF-α inhibitor treatment on patients of Indian origin suffering from HS.

  • DRESS Syndrome Induced by Sulfasalazine, triggered by Ceftriaxone and Improved with N-acetyl cysteine

    view case study

    Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a delayed type of systemic hypersensitivity reaction caused by the intake of anti-convulsants, allopurinol, sulfasalazine, NSAIDs and other drugs. It is characterized by maculopapular rashes, fever and eosinophilia affecting the systemic features. This syndrome is severe and fatal than acute drug reaction as it affects internal organs as well. Intake of certain antibiotics, especially the β-lactams such as amoxicillin, may trigger the reaction in the patients of DRESS syndrome. Our client needed a case study for their KOL on a patient who was suffering from DRESS syndrome induced by sulfasalazine and aggravated by ceftriaxone. A prompt withdrawal of sulfasalazine along with intake of systemic corticosteroids and N-acetyl cysteine was found to be useful for a such life-threatening condition.

PHYSICIAN’S PERCEPTION MAPPING AND CLINICAL PRACTICE GUIDELINES
  • Alzheimer’s Disease: Community Research Findings

    view case study

    Alzheimer’s disease (AD) remains one of the most pressing challenges in neurology, with growing research efforts aimed at advancing understanding and improving outcomes. For this project, our client sought support in communicating findings from a survey conducted among neurologists, focusing on their perspectives, experiences, and insights related to AD management.

    We collaborated closely with the research team to translate the insights into a clear, scientifically accurate, and audience-friendly communication piece. Our deliverables included a concise press release, highlighting key physician perspectives, emerging practice patterns, and perceived unmet needs. In addition, we developed a technical note outlining the survey design, methodology, and respondent profile, supporting credibility and scientific rigor.

    Therapy area: Neurology, Alzheimer’s Disease

  • A multifaceted approach for diabetes management in India

    view case study

    Diabetes is a serious health burden and is on the rise across the world. India is no exception with a large population being affected with this condition and newer therapeutic regimes are required for better control. Our client wanted to conduct a survey to understand the view of Indian physicians and endocrinologists regarding the available therapeutic considerations for type 2 diabetes treatment. A questionnaire focusing on issues pertaining to lifestyle intervention prior to initiation of medication was distributed among the physicians working at several primary secondary and tertiary care centers across India. Based on the data from the questionnaires, it was concluded that for newly diagnosed type 2 diabetes, lifestyle intervention was most preferred before pharmacological therapy. Additionally, most physicians preferred metformin as the OHA of initial choice. Drugs of second choice included one of the α-glucosidase inhibitors and DPP4 inhibitor, which were preferred over sulfonylureas.

  • Good Clinical Practice Recommendations (GCPR) for the use of Combined Hormonal Contraceptives

    view case study

    Combined Hormonal Contraceptives (CHCs) belongs to a group of hormonal contraceptives. CHCs have been successfully used to reduce undesired pregnancies. With this clinical guideline the client wanted to promote awareness among Indian doctors regarding contraception methods and provide an update on the effectiveness and safety of CHC. We obtained clinical evidence from global studies, which was subsequently reviewed by the FOGSI expert committee before finalization of the guidelines. The final guideline addressed issues such as: 1) the unmet need for CHCs, 2) their usage (as contraceptive as well as non-contraceptive), 3) associated side effects, and 4) the importance of structured patient counseling. The guidelines also stressed on the CHC-associated safety concerns including contraception in special situations and provided information on patient counseling tips as well as ways to tailor CHC usage as per the patients’ need.

    This guideline was considered the FOGSI Position Statement on the use of Progestogens. Combined Hormonal Contraceptives: Counselling and Use in Clinical Practice.

  • Deriving expert consensus to enhance optimal implementation of thromboprophylaxis after major orthopaedic surgery

    view case study

    Venous thromboembolism (VTE) is a global health concern with substantial morbidity and mortality. It is often asymptomatic and under-diagnosed, leading to long-term complications and reduced survival. VTE has also been identified as an immediate threat to patients undergoing major orthopedic procedures such as total hip arthroplasty (THA) and total knee arthroplasty (TKA). National Orthopedic Advisory Committee meeting was conducted to gain understanding of the clinical relevance of the International VTE prevention guidelines for orthopedic patients in India and to derive expert consensus to enhance optimal implementation of thromboprophylaxis after major orthopedic surgery for Indian population. We helped the client to have guided discussion for better VTE prevention after TKR and THR in Indian patients such as: 1) Thromboprophylactic agents, 2) Minimal duration of thromboprophylaxis, 3) Anticoagulation protocol with neuraxial anesthesia and indwelling epidural catheters, and 4) Bleeding management guidance. The guideline also focused on expert opinion on VTE prevention in patients with renal impairment, bilateral TKR / Revision surgery, mobilization and patient convenience, tolerability and adherence to therapy.

  • Role of TNF-α inhibitors in meeting the unmet needs of treating psoriasis in India

    view case study

    This particular anti-TNF-α factor, is considered effective not only in improving clinical symptoms of psoriasis but also in terms of quality of life. Our client wanted the current evidence from the systematic reviews, post-hoc analyses, registries and real-world data that would represent the associated benefit-risk of this anti-TNF-α factor and other biologics such as anti-T cell agents for psoriasis patients. It was found to be cost-effective and efficacious with no increased incidence of adverse events with escalated dosing. The proven post-marketing safety and efficacy phase, and ease of administration over infliximab are the additional benefits of the molecule.

Your Partner in Evidence
Synthesis and Market Access

india office

MarksMan Healthcare Communications Pvt. Ltd.

J1309, Amethyst Tower, PBEL City, Peeramcheruvu, Rajendra Nagar Mandal, Hyderabad, Telangana – 500091

singapore Office

MarksMan Healthcare Communications Pte. Ltd.

160 Robinson Road, #14-04 Singapore Business Federation Center, Singapore – 068914

Call Us: +91-9160467576

enquiry@marksmanhealthcare.com

Latest Blogs

  • Sustainable Value: How HEOR is Transforming Carbon Accountability in Pharmaceutical Supply ChainsDecember 16, 2025
  • Developing an RWE-Driven Strategy for Formulary and Access DecisionsDecember 9, 2025
  • Usefulness of Subject Headings for Literature Search in DatabasesDecember 4, 2025

Quick links

  • About Us
  • Case Studies
  • Publications
  • Careers
  • Contact Us

Work with us

We believe that work is to be pursued and enjoyed through commitment, teamwork, creative thinking, and an ethical approach in everything we do. Apply for CAREERS and explore current openings

Copyright © 2025 Marksman Healthcare Communications

Crafted by LUBUS