CluePoints and the Alliance for Clinical Research Excellence and Safety (ACRES) announce a strategic agreement to join forces in identifying potential risks to the quality of data at clinical research sites involved in drug development. An initial focus will be the development of cost-effective tools to streamline on-site monitoring through application of CluePoint’s innovative statistical monitoring methodologies.
26 March 2015
Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, and the Alliance for Clinical Research Excellence and Safety (ACRES), a multi-sector non-profit organization dedicated to building a stakeholder-driven integrated global system for clinical research, today announced a strategic partnership. The agreement will bring CluePoints into the ‘ACRES Alliance’, a rapidly growing collaborative of excellence-minded, innovation-focused organizations from across the global clinical research enterprise, and will focus on improving data quality in clinical research by identifying potential risks at investigative sites.
The collaboration will initially explore opportunities for streamlining and improving effectiveness of on-site monitoring visits by bringing CluePoints’ CSM solutions to the ACRES shared global platform of integrated technologies, with the goal of improving the integrity of data and reducing trial costs. CluePoints and ACRES will also explore the potential of building the CSM solution into ACRES’ global system to identify operational and performance problems in a trial before they actually happen, using historical databases of data quality and performance indicators from selected investigative sites. In addition, CluePoints will participate in ACRES’ Foundation Initiatives related to quality management, site accreditation and standards, contributing to the “dynamic accreditation” process being developed by the Alliance.
“CluePoints and ACRES share a belief that data quality is paramount to ensuring successful drug development programs and the responsible and ethical conduct of research”, comments François Torche, CEO, CluePoints. “We believe that as part of the ACRES Alliance and Technology Consortium, we can work together to address the industry’s challenges and raise the bar for monitoring methodologies that will transform the industry.”
ACRES President and CEO, Dr. Greg Koski, said, “We have a great opportunity, and pressing need, to develop an open-access global network of shared technology platforms, standards and processes to enhance performance, quality and safety in clinical trials through integration of existing innovative technologies. We are delighted that CluePoints, a leading innovator in the risk-based monitoring space, has joined this initiative. With our shared global reach and dedication to enhancing the integrity and efficiency of clinical trials, we aim to re-shape data-monitoring to benefit all stakeholders, including sites, sponsors, CROs, regulatory agencies and patients.”
Conventional quality systems are widely acknowledged as time-consuming and expensive for all involved, commanding more than a third of the cost of drug development programs. CluePoints’ CSM solution will provide ACRES access to the SMART™ engine which uses statistical scoring algorithms to identify investigative centers whose data are inconsistent with data from other centers engaged in the same trial and supports a cost effective approach to robust statistically-driven risk-based monitoring and quality assurance strategies. CluePoints and ACRES will now work collaboratively to bring these capabilities to a global system for clinical trials, ensuring that trials are conducted according to the highest standards of safety, quality and efficiency.
For further information on CluePoints, 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.
The Alliance for Clinical Research Excellence and Safety (ACRES), a non-profit multi-sector alliance working in the public interest, brings together diverse stakeholders across clinical research, harnessing their expertise and investments to collaboratively build an open, integrated global system, based in principles of Accountable Research™. Adapting lessons from industries that successfully implemented principles of systems and safety engineering, such as transportation, communications and information technology, this system will employ integrated information technologies and interoperable standards, policies and practices to enhance clinical research safety, quality and efficiency to benefit stakeholders worldwide, especially patients.
For more information, visit www.acresglobal.net
Patrick Hughes – Chief Commercial Officer, CluePoints
+44 (0) 7703 532 749
Mary F Tobin, Ph. D – Special Advisor to the President/CEO, ACRES
+1 410 987 5509