Combined solution can help identify trial risks in operational and clinical data before traditional methods
22 April 2015
Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced their collaboration with Oracle Health Sciences, combining CluePoints’ award-winning 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’ Central Statistical Monitoring (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.
“We are thrilled to be working with Oracle Health Sciences on the integration of our technologies,” says Franҫois Torche, CEO, CluePoints. “It is well understood how vital accurate data is to a clinical trial. By bringing together a combined technology solution, customers can now proactively resolve risks and ensure that they have detailed insight into data at all stages of a clinical trial.”
CluePoints and Oracle Health Sciences have announced an upcoming webinar, entitled ‘De-risking It All – A Systematic and Proven Approach to RBM and Data Quality Oversight”, providing the opportunity to learn from industry experts how a unique combination of data analytics and Electronic Data Capture is being harnessed by large, medium and smaller Pharma to de-risk clinical studies and drive Risk-Based Monitoring. To register, please visit https://xtalks.com/RBM-and-data-quality-oversight.ashx
For further information on the CluePoints Central Statistical Monitoring Solution, please visit www.CluePoints.com
CluePoints® is a Central Statistical Monitoring solution that has been designed and perfected over the last 12 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 FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.
Chief Commercial Officer, CluePoints
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