Risk-Based Analytics: The New Backbone of Trial Monitoring

Traditional monitoring visits catch issues late. Risk-Based Monitoring (RBM) shifts the posture — using data to prioritize where a human should look next. At Proclin, RBM is powered by our in-house AI-native CTMS, which continuously scores sites on protocol deviation velocity, query aging, AE reporting cadence and enrollment shape.

Inside a single dashboard, our CRAs and central monitors see risk trending across every site — with drill-down to the specific participant, visit or query behind the signal. Because the CTMS is validated against 21 CFR Part 11, every alert is auditable back to source data.

The result: fewer wasted site visits, earlier corrective action, and cleaner databases at lock. For sponsors, that translates into shorter timelines and lower cost per patient.