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

Abstract

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.

Total integrated performance excellence system (TIPES): A true north direction for a clinical trial support center

“…An integrated quality system provides value to an organization by promoting and sustaining a culture of quality and performance excellence, mitigating the risks associated with multicenter clinical trials and protecting the research participants [ 5 ]. Tsiakals [ 6 ] adapted Maslow's hierarchy of needs to create a quality hierarchy (QH) founded on ISO 9001:2000.…”

Evaluation of opportunities for the use of modern methods for correction and prevention of risks in the quality control of clinical trials

“…The analysis of the selected publications showed (Table 1) that the key issues highlighted in them were the study of factors that determine the need for implementation of QMS in CT, the establishment of an effective system of quality management that operates at all stages of organizing and conducting of CT, management of non-conformances within the framework of the CT quality management concept, application of the Quality-by-Desing concept for quality management during organizing and conducting of CT, as well as the benefits of using risk-based monitoring [4][5][6][7][8][9].…”

“…2. Reasons for the need of the CTQMS implementation according to the regulatory authorities' opinion Another key aspect that was addressed in the analyzed publications was CT quality management, taking into account the Quality-by-Design concept, which is based on risk-oriented approaches to quality [7][8][9].The key to these approaches is the early detection of possible risks for the CT quality, their correction and prevention of appearance in the future. This task could be solved through the conducting of monitorings, inspections, audits, which benefits both the CS and the regulatory authorities.…”

Process Management Framework: Guidance to Successful Implementation of Processes in Clinical Development

“…The TransCelerate clinical quality management system (CQMS) conceptual framework 1 highlighted process as a primary and integral element of a CQMS. The intent of this paper is to define a conceptual framework for implementing processes in clinical development.…”