THE INTERSECTION OF ARTIFICIAL INTELLIGENCE AND REGULATORY COMPLIANCE IN CLINICAL TRIALS

Abstract

The confluence of artificial intelligence (AI) and regulatory compliance within the realm of clinical trials represents a transformative paradigm in the healthcare and pharmaceutical industries. This review article examines the multifaceted relationship between AI and regulatory compliance, shedding light on their interplay and impact on the conduct of clinical trials. It delves into the evolving role of AI in optimizing patient recruitment, data analysis, and drug development processes, emphasizing the myriad advantages in terms of efficiency and cost-effectiveness. Regulatory compliance, governed by stringent guidelines and ethical standards, plays a pivotal role in ensuring data integrity and patient safety. This article explores how AI assists in meeting regulatory requirements, citing case studies to exemplify its influence on compliance efforts. It also addresses the pivotal areas of data integrity and security, ethical and legal considerations, and the future challenges and opportunities associated with AI-driven clinical research. The conclusion underscores the necessity of harmonizing AI-driven innovations with regulatory standards and the collaborative responsibility of stakeholders in navigating this transformative intersection.