Current Edition

Improving Data Quality for Risk-Based Monitoring and Data Review

With continued efforts to improve clinical processes, risk-based monitoring (RBM) approaches are becoming increasingly important for sponsors and CROs. Petra Cramer of eClinical Data Services, PAREXEL Informatics explores RBM strategies, which involve identifying study risk factors including data quality, entry and review cycle times, incidence of adverse events and other measures – all to provide cost-effective decision-making for utilising clinical monitoring resources.