Developed from real sponsor and CRO implementation experience, this guide helps clinical teams apply RBQM principles consistently across oversight, risk management, and study execution activities.
As clinical trial oversight becomes increasingly risk-based under ICH E6(R3), teams are expected to apply RBQM consistently across study design, oversight, monitoring, quality management, and operational decision-making.
This guide was developed to help clinical research professionals operationalize RBQM in real study environments. It combines practical implementation concepts, regulatory expectations, and lessons learned from sponsor and CRO settings.
Topics covered include:
The book is designed for professionals involved in clinical operations, centralized monitoring, QA, data management, medical oversight, and RBQM implementation activities.
Artem Andrianov is CEO and co-founder of Cyntegrity and has over 25 years of experience in clinical data quality, biostatistics, and risk-based clinical trial oversight.
His work focuses on applying data-driven RBQM approaches to improve oversight consistency, risk evaluation, and operational decision-making across clinical trial environments. Artem has contributed extensively to the practical evolution of RBQM implementation within sponsor and CRO organizations.
He holds a PhD in Mathematical Modeling and an Executive MBA.
Johann Proeve is Chief Scientific Officer at Cyntegrity and brings more than 40 years of experience in clinical data management, quality oversight, and operational RBQM implementation.
Formerly VP Global Data Management at Bayer Healthcare, Johann has supported sponsor and CRO organizations in applying practical RBQM strategies across clinical operations, monitoring, and quality management activities.
He is a recognized speaker and contributor within the RBQM community and lectures in Pharmaceutical Medicine at the University of Duisburg-Essen.
