CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 15 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the ICH, FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring, medical review and to drive a Risk-Based Monitoring strategy.
Determine study risks by using CluePoints’ customizable Risk Assessment Categorization Tool (RACT), which is built in line with TransCelerate’s risk assessment methodology
Establish operational workflows to ensure that all stakeholders within the team understand their roles and responsibilities
Immediately identify ‘at risk’ sites, patients and data and track corrective actions to successful conclusions, all within the platform
Track risk evolution over time and determine how corrective action has mitigated ongoing issues