Current Edition

Retooling Risk-based Management Using AI

As a clinical trial monitoring technique, risk-based monitoring (or RBM) has become the R&D industry’s de facto monitoring approach to achieve quality data, patient safety, protocol compliance, and efficiency. Moving away from 100% source data verification (SDV), RBM approaches emphasise critical data and processes and are designed to manage potential differences in the quality and experience of clinical trial sites. Sandra H. Blumenrath at DIA Global looks at how recent debates have focused on how technology can support improvements in compliance, quality, and consistency.