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06May
The Role of Real World Evidence in Optimizing the Conduct of Clinical Trials
Real-world evidence (RWE) is derived from real-world data (RWD) sources, such as electronic health records (EHRs), claims data, data from product/disease registries, pharmacy data, social media, and pragmatic trials. RWE […]
13Dec
The Evolving Role of Medical Affairs Professionals
in Clinical Trials
The role of the medical affairs (MA) professional is constantly evolving, thanks to ever-increasing advancements and broadening scope of work in the pharmaceutical and healthcare domain. Of late, MA professionals […]
06Dec
Importance of Searching Clinical Trial Registries for Systematic Reviews
Results from over half of all conducted randomized controlled trials (RCTs), especially those with negative or unfavorable results, never get published. This means, searching only electronic databases that index published […]
04Oct
How Real World Data (RWD) can Support Conducting Smarter Clinical Trials
In a data-driven world, where everything can be digitalized, drug regulators and sponsors are increasingly looking beyond the confines of clinical trials. The use of real-world data (RWD) is becoming […]
13Mar
Impact of Information From ClinicalTrials.gov in the Conduct of SLRs?
Systematic literature reviews (SLRs) are classically conducted with an aim of mapping the complete evidence base of a particular healthcare intervention, which enables an impartial evaluation of the evidence and […]
29Dec
How Important is to Maintain Clinical Trial Transparency?
Clinical trials lay the foundation for the biomedical research enterprise. They not only assess the applicability of innovative laboratory findings in humans, but also generate robust evidence on treatments and/or […]
24Oct
How RWE can Impact Clinical Trial Design and Help in Decision Making?
Real-world evidence (RWE) research is gaining significant importance in biopharmaceutical product development as well as its commercialization. The increasing need of the industry to seek broader information about the safety […]
06May
What are the Strategies for Effective Retention in Clinical Trials?
The most recent evidence shows patient recruitment and retention issues to be a persistent problem in clinical trials. Also, it is almost certain that this problem will only continue to […]
14Sep
How Strong is the Evidence for Drugs Receiving FDA Accelerated Approval?
A recently published study by Dyer O (2017) exposed major drawbacks in the accelerated approval process of some drugs available to the American patients without any stringent clinical evidence of […]