CluePoints is the premier provider of Risk-Based Monitoring and Data Quality Oversight Software. Our products utilize statistical algorithms to determine the quality, accuracy and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and the new ICH (E6) addendum, CluePoints is deployed to support traditional monitoring and data management and can be implemented as the ultimate engine to drive Risk-Based Monitoring. The value of CluePoints lies in its powerful and timely ability to identify anomalous data and site errors allowing optimization of central and on-site monitoring and a significant reduction in overall regulatory submission risk.
CluePoints works in the same way that other industries interrogate data to reduce insurance risk, detect credit card fraud, provide national security intelligence and even select players for sports teams. These sectors rely on this type of comprehensive statistical approach, and the clinical industry is now enjoying the same benefits in terms of risk mitigation, operational effectiveness and reduced costs.