Clinical Research

Informed Consent Procedure in Clinical Trials

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Informed Consent in clinical trial is often the most important part of clinical trial and sometimes neglected too, resulting in serious consequences, for the patient, the doctor involved in the trial and the pharmaceutical company sponsoring the trial. Which brings us to the question of what exactly is an Informed Consent Procedure? It is process […]

Clinical Research

Development of Malaria Vaccine in Africa

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Malaria continues to be widespread disease in killing more than 2 million people annually in Africa. The sub Saharan desert registers the most number of cases of malaria with a whopping 90%.  The World Health Organization, estimates that in the year 2010, malaria killed an estimated 660000 people, mostly children. It is estimated by the […]

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 […]