Authors: Dr. Kavita Sharma, Mr. Rohan Mehta
ABSTRACT: Pharmacovigilance in clinical trials plays a pivotal role in ensuring patient safety, drug efficacy, and ethical conduct during drug development. It encompasses systematic processes to monitor, identify, assess, and prevent adverse drug reactions (ADRs) throughout trial phases. The discipline not only addresses regulatory compliance but also strengthens clinical decision making and post-marketing surveillance. This paper explores the scope, challenges, regulatory frameworks, and technological advancements in pharmacovigilance during clinical trials, emphasizing its contribution to modern drug safety systems.
KEYWORDS: Pharmacovigilance, Clinical Trials, Adverse Drug Reactions, Regulatory Framework, Drug Safety
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