Parexel Strengthens Risk-Based Monitoring Offering with New Advanced Statistical Capabilities
BOSTON--(BUSINESS WIRE)-- PAREXEL, a leading provider of Clinical, Consulting and Commercial solutions to accelerate the development of innovative new therapies to improve the world’s health, today announced its strategic collaboration with CluePoints, an industry-leading provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software, to enhance overall data quality oversight and ensure regulatory compliance within clinical trials. Through the collaboration, Parexel and CluePoints aim to drive the quality, accuracy, and integrity of clinical trial data both during and after study conduct as well as increase productivity, efficiency and cost-effectiveness for sponsors.
“A proactive risk management strategy to protect patient safety and ensure high-quality data is at the foundation of every clinical trial we conduct,” said Gadi Saarony, Executive Vice President and Chief Clinical Research Services Officer, Parexel. “The addition of the CluePoints’ CSM solution enables us to look at Risk-Based Monitoring (RBM) differently and from a holistic point of view so that we can focus monitoring activities where they are needed, ultimately driving increased efficiency and productivity while identifying and addressing risks before problems arise.”
With the adoption of ICH E6 (R2), establishing new requirements to facilitate the mutual acceptance of clinical data by regulatory authorities, there is a greater need to generate higher-quality data in a timely and cost-efficient manner. The addition of CluePoints’ CSM technology to facilitate the early identification of anomalous data, optimize on-site and central monitoring and reduce overall regulatory submission risk, coupled with Parexel’s extensive industry experience and RBM expertise, will help to meet the evolving needs of the industry and deliver safe and effective treatments to patients.
“Our vision of RBx, where independent data interrogation, comprehensive analysis, and resulting actions become reusable knowledge, is enabling the industry to progress efficiencies and further improve quality for sponsors,” commented Patrick Hughes, Chief Commercial Officer at CluePoints. “CluePoints is looking forward to working closely with Parexel’s data surveillance experts to identify, assess, plan, mitigate, monitor and analyze risk across all elements of clinical trial management, using technology to comply with regulatory requirements.”
CluePoints is a premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software. Our products utilize comprehensive 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, EMA, and ICH E6 (R2), CluePoints® is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have the tools needed to adhere with global regulatory guidance. The result is increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBx.
Parexel is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science and biopharmaceutical customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do. For more information, visit our website and follow us on LinkedIn, Twitter and Instagram.
Parexel is a registered trademark of Parexel International Corporation. All other trademarks are the property of their respective owners.