Risk-Based Quality Management: The Importance of Risk Communication
June 19th 2019Amid the recently released ICH E8 (R1) draft guidelines further supporting RBM strategies, practical methods for integrating critical-to-quality (CTQ) factors within the operational execution life cycle of a clinical trial are presented.
Predicting Investigator Site Enrollment Performance: Separating Myth from Truth
June 17th 2019A trial’s success depends on enrolling the planned number of patients in the shortest possible time frame. Such thinking can insight a limited focus on obtaining and analyzing all investigator site enrollment data - as if that would solve all problems pertaining to site enrollment performance, writes Gen Li, President of Phesi.