Risk-Based Monitoring

The FDA has been encouraging an innovative, centralized, and statistically driven approach to monitoring clinical trials to enhance human subject protection and the quality of trial data. Yet the pace of data generation, and the complexity and volume of the data produced, have exceeded the capabilities of most existing informatics solutions. Program, country, and study managers, CRAs, clinical monitors and clinical trial managers, clinical data managers, CROs, and others need informatics solutions that help them focus on sites in greatest need, based on risk.