The following materials provide an insight into the work and progress of the TransCelerate QMS Initiative:
- September 2016: A Knowledge Management Framework and Approach for Clinical Development – This paper outlines in general terms key elements of a clinical knowledge management (CKM) framework to assist clinical development organizations in understanding its benefits and basic components. Ideas are provided at a high level for flexible approaches and solutions aimed to enhance knowledge gathering, sharing, application, and retention within clinical development.
- July 2016: TransCelerate’s Clinical Quality Management System: Issue Management – Issue management is one of the elements of the TransCelerate clinical QMS conceptual framework and this article explores this element in depth.
- May 2016: TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework – 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.
- Our Clinical QMS Overview Infographic gives a quick snapshot into our conceptual framework. Check it out
- September 2015: Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and Outline – Our paper provides an initial outline of a proposed conceptual framework for a clinical QMS, an integrated system through which a sponsor organization can systematically plan and achieve clinical quality goals linked to their broader clinical and company strategic goals. The paper also explores how a clinical QMS framework can help alleviate issues related to trial inefficiencies that delay the process of bringing new, lifesaving medicines to patients.
- For a basic overview about QMS click here.