CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, introduced software to enable analyses of operational data using a risk-based monitoring approach.
CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, introduced software to enable analyses of operational data using a risk-based monitoring approach. The new software includes Key Risk Indicators (KRIs) that complement the statistical analysis of clinical data. This KRI+ approach allows sponsors and CROs to set their own subjective threshold levels, while also statistically examining data objectively to show how a single site's KRIs can be judged against results across all other sites.
Industry Assessment of Risk-Based Quality Management Emphasizes Value of Adoption
April 4th 2024A study conducted by the Tufts CSDD in collaboration with CluePoints and PwC revealed that slightly more than half of sponsors and contract research organizations have adopted risk-based quality management approaches.