Centralized Monitoring in Early Phase Clinical Trials

Quality is the foundation of clinical trials. Without quality, it is not possible to produce trustworthy data to ensure the protection of trial participants. Quality is defined as the absence of meaningful errors1 that impact critical trial processes or data. These are the Critical to Quality (CtQ) factors that affect participant rights, safety, wellbeing, data integrity, and the very information required to answer the question the protocol poses.