Clinical research and regulatory affairs is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. It is also concerned with investigating the influence of population and biological diversity as well as disease states on responses to treatment. The results of clinical research studies (especially clinical trials) are essential for gaining approval for marketing new medications and devices or new indications of existing products from regulatory agencies throughout the world.
India has one of the largest patient populations for most diseases with genetic diversity. Combined with the large pool of highly qualified medical practitioners in the country and with implementation of Good Clinical Practice (GCP) as per the International Conference on Harmonization (ICH) standards, it is attracting serious global interest as a site for clinical trials. As per the recent McKinsey report on clinical trials in India, it is estimated that the industry potential will grow to $1 billion. This expectation has created a demand for more clinical research professionals.
This novel program provides necessary training for graduate students in order to develop diverse careers as Clinical Research Associates (CRA), Medical Writers, Clinical Data Coordinators, Drug Development Associates, Business Development Managers, Clinical Project Manager, Clinical Research Manager, Regulatory Affairs Manager and Biostatisticians in Contract Research Organizations (CROs), pharmaceutical companies, government agencies or academia.
Master of Science in Clinical Research & Regulatory Affairs (MScCRRA)
