CluePoints, a Cambridge, Mass.-based provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, is collaborating with Oracle Health Sciences, combining CluePoints' risk-based monitoring (RBM) solution with Oracle’s clinical data capture and management platform, Oracle Health Sciences Inform Cloud Service. The resulting solution can help deliver a complete trial review process that proactively identifies risk in both clinical and operational data throughout a clinical trial. These include operational risks, such as those outlined by industry consortiums, as well as risks seen through the analysis of clinical data that highlight anomalies or inconsistent data patterns at study, region or site levels that otherwise may not have been identified.

This collaboration brings together CluePoints' CSM solution, which identifies anomalous data and site errors, with clinical and operational data from Oracle Health Sciences to analyze and identify risks, and ultimately optimize both remote and on-site monitoring. By offering sponsors and CROs full evaluation and proactive identification of risks identified through both clinical and operational data, customers are able to respond to signals and anomalies that could impact patient safety and the quality of results, while also driving informed decision-making for future stages of a trial and minimizing subsequent regulatory submission risk.

The combination of CluePoints' solution and Oracle's holistic RBM cloud platform can allow identification of risks based on patient data, site level or region using clinical data from the InForm platform, and, as a result, complementing existing RBM capabilities that identify operational risks for a study. The detection of risks identified through both operational and clinical data provides customers with the ability to fully respond to data issues and make changes to study protocols to effectively address and minimize study risk.

Franҫois Torche, CEO, CluePoints, said, "It is well understood how vital accurate data is to a clinical trial. By bringing together a combined technology solution, customers now can proactively resolve risks and ensure that they have detailed insight into data at all stages of a clinical trial."