Navigating the Horizon: Current Trends in Elevating Quality Assurance in Clinical Research
Patil Divyashree Kantilal, Patil Bhagyshri Sandip, Patil Bhushan Ravindra, Patil Divyani Rajendra, [This article belongs to Research & Reviews: A Journal of Drug Design & Discovery(rrjoddd)]
Keywords
Data integrity, Inspection, Quality systems, Risk-based monitoring, Subject protection.
Abstract
The landscape of clinical research quality management has evolved significantly in recent years, driven by stringent regulatory frameworks and the globalization of trials. This evolution underscores the importance of integrating quality into all aspects of the clinical trial process, from design to post-research activities. Concepts such as Good Clinical Practice (GCP) and Quality by Design (QbD) are central to ensuring the reliability and accuracy of trial data while safeguarding patient safety and welfare. Challenges in quality assurance include the complexity of studies, the outsourcing of trial activities, and the need for continuous monitoring and improvement. The convergence of emerging technologies and evolving regulatory frameworks, complemented by collaborative endeavors among industry, academia, and regulatory bodies, is significantly influencing the trajectory of clinical research quality management. This collective effort aims to enhance the integrity, efficiency, and safety of clinical trials globally, fostering continual advancements in the field. Moving forward, integrated quality management plans, end-of-research reporting, and knowledge sharing will be key to advancing the quality and integrity of clinical trials worldwide.
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