Strategic partnership will bring together CluePoints’ Risk-Based Monitoring Software with Bracket’s Rater Training and Quality Assurance Services for CNS trials
6 October 2015
Cambridge, MA – CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials, today announced a partnership with Bracket Global, a leading provider of technologies and services that drive superior clinical outcome results. The exclusive partnership will see CluePoints’ RBM software offered in combination with Bracket’s Blinded Data Analytics and Rater Training and Quality Assurance oversight program for psychiatry and neurology trials. Bringing together CluePoints’ and Bracket’s expertise and solutions will enhance the impact of the services that each company delivers to sponsors, improving the integrity and quality of clinical data.
As the recognized leader in Rater Training and Quality Assurance, Bracket is an ideal partner to offer CluePoints’ Central Statistical Monitoring (CSM) solution that delivers an agnostic approach to RBM and Data Quality Oversight by using statistical methodology to identify unusual patterns in clinical trial databases. Bracket’s long track record of helping sponsors achieve better signal detection and develop clinical quality assurance programs, ideally aligns the company to promote the value of CluePoints’ software in detecting potential data quality problems in CNS trials.
“We are delighted to announce our partnership with CluePoints, a company which is leading the way in software that can support the practical implementation of RBM techniques in today’s trials”, comments David Daniel, Sr. Vice President & Chief Medical Officer, Bracket Global. “Integrating CluePoints software into Bracket’s Electronic Clinical Outcomes Assessment-based data quality monitoring programs provides a level of efficiency and sophistication in de-risking CNS studies that has not previously been possible.”
CluePoints’ CEO, Franҫois Torche, said: “CluePoints experience of de-risking over 50 studies using our unique CSM solution, along with Bracket’s world-leading expertise in delivering quality assurance systems, provides us with a unique opportunity to deliver combined services that achieve the most detailed insight into clinical data for sponsors. Working together we will support CNS trials in improving data quality and integrity using independent, objective statistical methodology.”
CluePoints and Bracket have been selected to present during the “Innovation Showcase” at the 2015 CNS Summit on October 9 in Boca Raton, Florida. Patrick Hughes, Chief Commercial Officer at CluePoints, will present “Integrating Central Statistical Monitoring in Clinical Quality Assurance Systems” to an annual gathering of drug development leaders from pharma, sites, and service companies.
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.
Bracket, with seven offices and more than 500 employees worldwide, is a Specialty Services provider dedicated to helping pharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic Clinical Outcomes Assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable Clinical IRT solution for the life sciences industry. Bracket Rater Training and Quality Assurance improves outcomes through customized training and quality assurance programs
Patrick Hughes – Chief Commercial Officer, CluePoints
+44 (0) 7703 532 749