TransCelerate BioPharma Inc.,

TransCelerate BioPharma Inc. is a non-profit organization created to improve the health of people around the world by simplifying and accelerating the research and development of innovative new therapies. TransCelerate has developed a risk-based monitoring methodology that transforms clinical trial monitoring into a comprehensive approach leveraging cross-functional risk assessment, technology, and adaptive on-site, off-site, and central monitoring activities to ensure data quality and subject safety. This article assesses the value of SDV in clinical trial monitoring via a literature review, a retrospective analysis of data from clinical trials, and an assessment of findings from TransCelerate member company internal audits.