CluePoints' web-based CSM solution to help sponsors evaluate quality, integrity of clinical trial data

CluePoints' solutions are driven by the company's intelligent, patent-pending SMART™ engine that provides customers with the ability to check data quality across all clinical subjects, sites, regions and countries involved in a trial, achieving data consistency, while documenting where and why any anomalies have occurred. Aligned with current FDA and EMA recommendations, the approach ensures that users are able to identify signals in study datasets and can make timely decisions about which sites to target for monitoring activities, resulting in reduced regulatory submission risk and costs.

This first version of the web portal aims to put the sponsor in control so that they can run the analysis, set-up the SMART engine, construct and manage data within the system, select appropriate statistical tests and perform the complete CSM process independently and objectively. Continuous improvements will be brought to the software to meet clients’ needs: a second release will soon support closer to real-time assessments of data and generate a customized report whenever required.

"The launch of CluePoints' web-portal marks another exciting industry first for CluePoints as it enables sponsors and contract research organizations (CROs) to drive their own analyses using actual clinical data, rather than just subjective operational metrics, for the first time", comments Franҫois Torche, CEO of CluePoints. He continues: "We are continually working to enhance the usability of our solutions to meet current industry needs and through discussions with our clients have found that many companies would like to take full control of their risk-based monitoring analyses using clinical databases. The new SaaS solution enables them to do this."

To offer sponsors and CROs detailed insight into the practical implementation of CSM solutions, a new webinar from CluePoints in collaboration with Sanofi Aventis is now available online, entitled 'Risk-Based Monitoring – What we’ve learnt in a year, a Large Pharma Perspective from Sanofi'. The session demonstrates how CSM techniques have been harnessed to improve data quality and oversight, while showcasing the impact that Sanofi has had on enhancing this technology-driven approach.