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What is Clinical Research?
A Clinical research is a scientific study of the effects, risks, efficacy and benefit of a medicinal product. These are carried out prior to the release of the medicine in the market. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use. Clinical trials are conducted by Pharmaceutical companies or Contract Research Organization (CROs) / Site Management Organization (SMOs) on their behalf. It is this sector that is driving the growth in Clinical Research in India.
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
Drug Development
Drug development is a blanket term used to define the entire process of bringing a new drug or device to the Market. It includes Drug discovery / product development, pre-clinical research (microorganisms/animals) and Clinical trials (on humans). |
