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Clinical Trial

A Clinical Trial, also called Clinical Studies and Medical Trials, is conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place. Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.

Annegret Van der Aa

In this interview Annegret Van der Aa, Clinical Trial Manager, Galapagos NV, shares her experience's of working in emerging markets; the main challenges that arise and approaches to overcoming them.

Pharma IQ: Changes to market conditions...

Contributor: Annegret Van der Aa
11/06/2011 07:00:00 PM EST
Pharma IQ

Mark Walls, Director of Clinical Pharmacy at Human Genome Sciences, speaks to Andrea Charles from Pharma IQ, about the logistical challenges facing clinical trials and avoiding common mistakes for logistics in emerging countries. He also talks...

Contributor: Pharma IQ
08/19/2010 08:00:00 PM EDT