CluePoints, a Cambridge, Mass.-based provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has partnered with the Alliance for Clinical Research Excellence and Safety (ACRES), a Massachusetts-based nonprofit dedicated to building a stakeholder-driven integrated global system for clinical research.
CluePoints also will join the ACRES Alliance, a rapidly growing collaborative of organizations across the global clinical research enterprise. Through the partnership, the companies will focus on improving data quality in clinical research by identifying potential risks at investigative sites.
The collaboration initially will explore opportunities for streamlining and improving the 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 also will 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 sites. In addition, CluePoints will participate in ACRES' Foundation Initiatives related to quality management, site accreditation and standards, contributing to the 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," said François Torche, CEO of 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."
Dr. Greg Koski, ACRES president and CEO, 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, an 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 now will work collaboratively to bring these capabilities to a global system for clinical trials.