Clinical trials and contract research organizations in India
1Quintiles Research Private Limited, Jacaranda Marg, DLF City Phase II, Gurgaon, Haryana, India. shoibal.mukherjee@quintiles.com
Abstract:
Economics and demography are driving drug development to the developing world. India needs this opportunity to build research skills required to combat its enormous disease burden. A variety of global and local contract research organizations (CROs) that specialize in the execution of research to develop health care products operate in India today. CROs assure quality and compliance to regulations while coordinating with tertiary providers such as a site management organization and the central laboratory. Back room operations to manage, analyze, and report data form a bulk of the employment generated by clinical research, absorbing programmers, data managers, biostatisticians,and medical writers. Despite rapid growth and strong potential, India remains a minor contributor to global pharmaceutical research because of policy stagnation, regulatory gaps, and misinformed controversies in the media.
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