CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced a web-based version of its intelligent risk-based monitoring platform that enables sponsors to determine the quality and integrity of their clinical trial data.
The web-based CSM Software as a Service (SaaS) offering will enable customers to control the upload of clinical data for assessment, visualize the findings and interact with analyses to make the understanding of results, comprehension of signals and identification of issues as intuitive as possible.
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 trial participants, 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 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 cost.
This first version of the web portal aims to put the sponsor in control so it 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 added 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 enables sponsors and CROs to drive their own analyses using actual clinical data, rather than just subjective operational metrics, for the first time," said Franҫois Torche, CEO of CluePoints. "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."