TransCelerate's Clinical Quality Management System: Issue Management.

Issue management is one of the elements of the TransCelerate clinical quality management (QMS) conceptual framework. Effective issue management benefits clinical development organizations by allowing them to focus efforts on those issues that materially impact patient safety, rights, and well-being; data integrity and/or scientific rigor; compliance with regulatory requirements; or trust in the clinical research enterprise, which have been defined as "Issues that Matter." Issue management begins with a triage of issues to identify those issues that materially impact as defined above, which are then handled by an end-to-end corrective and preventive action (CAPA) process.

TransCelerate's Clinical Quality Management System: From a Vision to a Conceptual Framework.

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.

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.