Abstract
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.
Highlights
Organizations 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
A Quality Management System (QMS) is an integrated approach through which an organization systematically defines quality objectives taking into account both its strategic objectives and applicable regulatory requirements and develops and implements the infrastructure, including the foundations, organizational structure, processes, and resources, required to achieve these objectives
While QMS have become ubiquitous across many industries, their adoption in the clinical development area has been challenging
Summary
A Quality Management System (QMS) is an integrated approach through which an organization systematically defines quality objectives taking into account both its strategic objectives and applicable regulatory requirements and develops and implements the infrastructure, including the foundations, organizational structure, processes, and resources, required to achieve these objectives. QMS are successfully used to promote and manage quality and to improve performance in complex environments in industries ranging from aviation to information technology. While QMS have become ubiquitous across many industries, their adoption in the clinical development area has been challenging. This paper offers a conceptual framework that will facilitate clinical development organizations in developing a QMS that is proactive, flexible, and tailored to the clinical environment. A QMS tailored to clinical development and the unique requirements of clinical development stakeholders can
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