Risk-based Monitoring

We use a combination of risk-based monitoring (RBM) and centralized monitoring (remote data review) approaches with occasional on-site visits for source data review (SDV) in our clinical monitoring.  This improves efficiency as well as protects study participants by focusing on the most critical elements of monitoring activities to enhance participant safety and ensure quality of the data collected in our different studies. Early development of a clinical monitoring plan and providing an ongoing assessment of the greatest risks to participant safety help prevent issues before they arise and ensure the highest quality and lowest error rate possible in the data collected.