The importance of quality assurance in clinical trials: Ensuring data integrity and regulatory compliance in the U.S. pharmaceutical industry
1 Regeneron Pharmaceuticals, New York, USA.
2 Department of Accounting, University for Development Studies, Ghana.
Research Article
World Journal of Advanced Research and Reviews, 2024, 24(03), 694–702
Publication history:
Received on 29 October 2024; revised on 04 December 2024; accepted on 06 December 2024
Abstract:
Clinical trials look into how medications affect people and try to find both the efficiency and safety of the treatment as well as any negative side effects. Clinical trial quality assurance is mostly determined by data consistency and subject safety, which calls for comprehensive quality control. This paper aims to evaluate the significance of Quality assurance practices in clinical trials particularly in the U.S. pharmaceutical industry. The objectives are to assess the role of quality assurance in maintaining data integrity, to examine regulatory requirements of quality assurance in the U.S., and to evaluate the impact of quality assurance on clinical trial outcomes. The paper used a comprehensive literature review and analysis of current quality assurance practices in clinical trials within the U.S. pharmaceutical industry including case studies, and expert insights. The findings revealed that effective quality assurance processes are critical for ensuring data integrity and regulatory compliance which significantly enhances the reliability of clinical trial results concerning drug safety and efficacy. It also showed that establishing clinical trial quality management plans is essential for outlining methodologies to uphold study quality particularly as clinical trials increasingly shift to developing nations where ethical and procedural disparities pose challenges. The paper concludes that the trend of outsourcing trial management necessitates robust quality assurance oversight to maintain standards while advancements in technology such as Electronic Data Capture Systems, enhance the efficiency of Quality assurance activities. Overall, the paper underscores that effective quality assurance practices are indispensable for maintaining participants' safety, ensuring data integrity, and contributing to the success of clinical trials.
Keywords:
Quality assurance; Good clinical practice; Quality-by-design; Clinical trials; Quality management plans
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Copyright © 2024 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0