Asian Journal of Pharmaceutical Research

Thakur Abhimanyu ¹, Kondru Sushmita ², Kamilya Shruti ³, Kumar Amit ¹, Goldar Epshita ¹

Affiliations
1 Department of Pharmaceutical Science and Technology, Birla Institute of Technology, Mesra, Ranchi, IN
2 Norwich Clinical Services Pvt. Ltd., IN
3 Manipal College of Pharmaceutical Sciences, Karnataka, IN

Abstract

Clinical trials play a major role in the process of drug discovery. It is mandated by the Food and Drug Administration (FDA), which aids in determining the safety and efficacy of investigational product (IP) prior to its marketing for mass consumption. The clinical trial site may be a research hospital, contract research organization (CRO) or any medical institute which allow subjects to access interventions not yet accessible to the mass population. Although human research give a ray of hope for the discovery of new drug, it also resulting in litigation against all the stakeholders of clinical study. This review explores the clinical trial liability exposure of subjects, and all other concerned stakeholders and also the mitigation strategies for this exposures and the prevailing misconceptions about insurance coverage. At the same time this article presents common clinical research scenarios that pose concern for fraud and abuse and offers suggestions for various relevant amendments required to bridge the gap.

Keywords

Clinical Research, Insurance Policies, Regulatory Affairs, Regulatory Case.

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