All posts by: MarksMan Healthcare

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Traditionally, systematic reviews are considered as the gold standard to inform clinical practice and policy decisions. However, systematic reviews are resource and time intensive. The time factor has been identified as a barrier to implementing results from evidence synthesis, as a result of an incongruence between the time required to produce a full systematic review […]

Heath Technology Assessment (HTA) is a scientific research area that makes informed clinical as well as policy decisions on the use of health technologies, which include pharmaceuticals, medical devices, diagnostics, procedures and other clinical, public health and organizational interventions. (1) Recently, ‘early HTA’ is progressively being promoted as a perspective to determine added value of […]

The concept of “Big Data” is #trending today, which is characterized by types of data sources with huge quantities, high speed and broad diversity of information. Healthcare industries are trying to apply Big Data analytics to reform data into a workable platform in order to generate information that would help making better and faster clinical […]

In recent years, patient-centric initiatives are becoming key factors among healthcare companies, as they are increasingly becoming aware of the fact that the key to growing business and improving customer health is to better focus on the needs and concerns of the patient, rather than attending to just the product approval. The objective behind patient-centric drug […]

The healthcare industry is challenged with administrative and regulatory intricacies that make achieving the healthcare objectives, such as better patient outcomes and reduced costs, difficult. Difficulties faced while improving patient outcomes are predominantly taxing, since health systems measure and report thousands of outcomes annually. (1) In addition, healthcare industry is saturated with the need for improved quality […]

Traditionally, the pharmaceutical industry has always been dependent upon the ‘push’ strategy for successful market access for products. The drug approval process, involving submission of data on efficacy, safety, and tolerability to the regulatory agencies, used to be simple; which ended with the drug being marketed to the targeted physicians and dispensed by pharmacies post approval. Thus, this whole process involved a limited set of stakeholders, viz. physicians, regulatory agencies, and pharmacies.

Drug development is a challenging and time-consuming procedure. An unmet medical need is a condition, the cure or diagnosis of which is not being addressed effectively by currently available therapies. To meet such an unmet medical need and treat severe diseases, Fast Track approval process has been introduced by Food and Drug Administration (FDA), which […]