The Quality Management System (QMS) initiative of TransCelerate BioPharma Inc has identified potential benefits that could be captured from the development of a flexible, proactive clinical QMS conceptual framework for clinical research. Such a framework would aid organizations in seamlessly managing the complex clinical trial environment and, ultimately, in expediting delivery of needed treatments to patients. This article chronicles the evolution of a TransCelerate concept paper describing a proposed clinical QMS framework and reviews feedback from varied global clinical trial stakeholders during socialization of the concept paper. Many stakeholders recognized the potential for the concept paper to inform development of a harmonized International Council for Harmonisation (ICH) guideline, providing needed clarity from regulators on their expectations for QMS in the clinical realm. Accordingly, the article also describes TransCelerate's efforts to work with regulators to facilitate harmonization on this important topic and reviews ongoing work to develop additional tools and resources that may support organizations in evaluating whether and how they might translate the conceptual framework principles into practice. KeywordsTransCelerate, QMS, clinical development, risk management, issue management, knowledge management, clinical quality IntroductionOrganizations engaged in drug development face an increasingly challenging environment: an expanding global footprint for clinical trials, evolving regulatory requirements, dynamic partnership models, and rapidly evolving technology. At the same time, many organizations are also innovating how trials are designed and conducted, adding to the complexity. Managing this complexity could be greatly enhanced by an effective and efficient Quality Management System (QMS). However, what constitutes an effective and efficient QMS is not well defined for clinical development. This article provides an update on the activities of a TransCelerate initiative developing a flexible, holistic, clinical QMS conceptual framework to address this gap. Initial Development of a Vision and Outline for a Clinical QMS Conceptual FrameworkThis TransCelerate effort started with identifying the gap in regulatory guidance for clinical trials. Prior to this, many organizations had been attempting to implement the International Council for Harmonisation Guidance Q10 (ICH Q10) for Good Manufacturing Practices (GMP), 2 or to follow other international standards dedicated to quality, such as ISO methodology.3 None, however, suited the unique circumstances of clinical trials. This issue, and other related quality issues, led TransCelerate to work to develop a vision and outline for a clinical QMS conceptual framework.1 This outline incorporated feedback from TransCelerate member companies on their existing clinical QMS, perspectives on QMS from other nonpharmaceutical industries, and key concepts (ie, risk-based thinking) from the revised International Organization for Standardization 9001 sta...
A quality management system (QMS) is an integrated framework through which organizations can systematically plan and achieve their quality objectives. While the International Conference on Harmonisation (ICH) Q10 provides clear guidance for QMS in the pharmaceutical manufacturing sector, there is no harmonized regulatory guidance describing a framework that provides an enterprise-wide view of achievement of clinical quality objectives, that is capable of being customized to fit an organization's unique circumstances, and that accommodates the variability inherent in clinical development. In the absence of such guidance, clinical QMS varies dramatically across industry, sometimes resulting in over-engineered, cumbersome systems that are not adaptable or fit-for-purpose. This paper will describe the ongoing activities of a TransCelerate initiative developing a conceptual framework for a Clinical QMS designed to provide a consistent, streamlined, and proactive quality approach across all stages of clinical research.
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