Parexel announced its collaboration with CluePoints, a 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,” said 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.”