Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and Outline.

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.