Central Statistical Monitoring solution tested by sponsors for ability to independently detect & interrogate anomalies in clinical trial data
12 January 2015
Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced that a web-based version of its intelligent risk-based monitoring (RBM) platform is being successfully tested by a number of key pharmaceutical sponsors, demonstrating new opportunities for the industry by providing users with complete control over the analysis of their clinical trial data. The SaaS solution drives RBM programs by putting the assessment of data integrity and quality firmly in the hands of sponsors themselves. As the first solution to offer this capability, sponsors of on-going clinical trials are finding increased efficiencies by using the solution to interrogate their own data, responding to signals and anomalies that could impact patient safety and the quality of results, while powering informed decision-making for future stages of a trial.
The announcement that the SaaS solution is successfully being implemented by sponsors comes at the same time that CluePoints has announced a new hosting partnership with IPERION, a specialist in GxP cloud computing and qualified IT infrastructure operating in the pharmaceutical, medical device, biotechnology and health care sectors. IPERION was chosen because of their expertise of the GxP cloud computing market and their robust and fast infrastructure. Qualified in line with GAMP and certified ISO 27001 and ISO 9001:2008, IPERION brings proven technology that will assist CluePoints in delivering the highest levels of performance to its customers. To further optimize the platform for users, 2015 will see CluePoints introduce further enhancements including better integration with EDC vendors, new visualization and graph features, as well as an action tracking system, all aimed at making the CSM process as streamlined and efficient as possible.
“What makes our SaaS solution really exciting, and why it has demonstrated great success for the sponsors who have tested the platform, is that for the first time we are putting the management of RBM activities at the fingertips of our customers”, says Franҫois Torche, CEO, CluePoints. “Sponsors and CROs are looking to manage trials with more detailed insight into the data that is being generated at all stages of a trial. The SaaS solution gives customers complete control, enabling them to focus on what matters most to a particular trial and allowing them to detect and respond to issues faster, mitigating the highest potential risks and delivering more predictable trial outcomes.”
CluePoints’ SaaS solution enables users to perform the complete CSM analysis, allowing them to control the upload of clinical data, visualize the findings and interact with analyses to make the understanding of results, comprehension of signals and identification of anomalies as intuitive as possible. Driven by CluePoints’ SMART™ engine, the solution enables customers to determine data quality across every clinical subject, site and region involved in a trial, achieving data consistency, while documenting where and why any issues have occurred.
For further information on the CluePoints SaaS 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 10 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.
Patrick Hughes – Chief Commercial Officer, CluePoints
+44 (0) 7703 532 749