Clinical Research

The Microdosing Concept in Clinical Trials

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Every professional in Clinical Trials will agree to the fact that clinical trials are an expensive, long and very complex activity. Sometimes it takes 10 to 15 years and billions of dollars for pharmaceutical companies to get their product marketed.  Statistics have confirmed reports that the number of molecules which enter the market to become […]

Clinical Research

Narrative Writing in Pharmacovigilance

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Narrative writing is an important part of Pharmacovigilance and in patient safety as well. Usually patient narratives are written in case of Adverse Events and Serious Adverse Events including deaths. Patient narratives form a very important part of clinical study reports and all other post marketing activities. In case of a Serious Adverse Event it […]

Clinical Research

The road to Vaccine Development – Tough albeit rewarding!!

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The process of vaccine development lasts for a minimum of 10- 15 years and needless to say, it is a very complex process. Of all the candidates selected for development, only a tiny percentage makes it to the final licensing state, which makes the process of vaccine development extremely expensive.  Vaccine development involves a combination […]

Clinical Research

Protocol writing in Clinical Research

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A clinical trial protocol is a legal document which outlines the study plan of the clinical trial in a detailed, yet comprehensive and concise manner. The protocol must provide a valid scientific rationale for the conduct of the clinical trial as well as make sure that the rights of the patient is safeguarded, maintaining the […]

Clinical Research

Self Help Groups / Patient Support Groups – Role in Clinical Research and Epidemiology

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A patient support group is constituted as a common forum or locus where patients with common diseases or interests can obtain information about their condition, share feelings and experiences and attain a sense of belonging and acceptance. Even though not being fully representative of the disease population, the pharmaceutical industry has long recognised the marketing […]