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

Clearly defined, documented, and managed processes form the foundation for how we effectively develop medicines for our patients. For this reason, process has been identified as a primary "element" of an effective quality management system (QMS) as described in the TransCelerate clinical quality management system (CQMS) conceptual framework. The importance of identifying and effectively managing processes is also emphasized in ICH GCP E6 (R2) in the new Section 5.0 Quality Management. An effective process management framework is fundamental to ensure the efficient and effective delivery of clinical development programs, enhance quality and productivity, and ultimately benefit our ability to deliver needed treatments to patients. The aim of this paper is to provide a conceptual process management framework to be used as guidance for effective process mapping, process documentation, implementation of optimal learning methods, and ensuring ongoing process performance evaluation and continuous improvement.