March 11th 2024
Analysis assesses the relative percentage of quality issues detected via SDM that clinical study teams considered critical.
Empower Centralized Monitoring with the Right Mix of KRI and CSM Reports
March 22nd 2017Centralized monitoring is the core of RBM and helps study teams decide on on-site monitoring activities and site intervention. Thus, the right mix of KRIs and Central Statistical Monitoring Reports is crucial for trial success.
Technology Implications for the New ICH Addendum
November 8th 2016The ICH is publishing its long-awaited guidelines on how to conduct clinical monitoring in trial management. Sponsors and CROs can integrate existing and emerging technologies while transforming their reactive oversight strategies to an RBM approach using these steps.