King of Prussia, PA – April 14, 2020: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials, today announced that EPS have entered into an agreement with CluePoints to offer Risk Based Quality Management (RBQM) solutions to its sponsors to drive early risk detection, improve quality and enhance patient safety in a cost-effective and resource-efficient manner.
Throughout the global Clinical Research and Pharmaceutical industry, RBQM is fast becoming an essential component to drive efficiency and quality and allowing sponsors and CROs alike to adhere to the regulatory mandates within ICH E6 (R2) published in 2016. CluePoints advocates a unique approach to ensuring regulatory compliance using Central Statistical Monitoring (CSM), an unsupervised, independent and objective analysis of all clinical and operational data. CSM is rapidly being adopted throughout Europe and North American as a proven method to identify risks earlier within the study lifecycle. EPS recognizes that CSM use in Japan can benefit both local and global trials and will be offering the pioneering methodology to all its clients.
EPS will be able to add a suite of RBQM tools to complement either new or existing RBM processes through the CluePoints Central Monitoring Platform. The platform offers a range of tools includes Risk Assessment, Key Risk Indicators, Data Surveillance, Patient Profiles, Data Visualizations, Duplicate Patients and Issues and Actions Management. The combination of these modules provides EPS and its clients with a systemic approach designed to increase the efficiency and effectiveness of study conduct. With guidance from EPS, sponsors are now able to choose the modules that will best suit their needs and that of their studies for successful implementation of RBQM. This approach is also being used by FDA, via a Cooperative Research and Development Agreement (CRADA), to select sites for regulatory inspection and to test treatment effect in different study populations.
Recent announcements by worldwide regulatory agencies such as FDA, EMA, PMDA and MHRA are quick to advocate the adoption of central and remote monitoring techniques in the wake of the COVID-19 pandemic. EPS recognizes that enhancing its own central monitoring capabilities using elements of the CluePoints Central Monitoring Platform will give their sponsors peace of mind that no stone is being left unturned in ensuring that issues are detected as early as possible and managed remotely. This is crucial for business and trial continuity within both new and ongoing studies and will include the use of COVID-19 specific Risk Assessment and Key Risk Indicators for risk planning and mitigation.
Patrick Hughes, CluePoints Co-Founder and CCO commented, “We are delighted to enter into this agreement with EPS as it demonstrates the pioneering approach to increasing the efficiency in conducting trials within Japan. The partnership comes at a time when remote monitoring of studies is the only option and we are keen to demonstrate to EPS and its sponsors how RBQM will improve the conduct of studies, not just at this critical time but for all time”.
EPS continues to contribute to the development of the medical and healthcare industries by constantly transforming and evolving itself, as the name of the company, “Every Progressing System”, shows.
CluePoints is the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software. Its 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 Quality Management (RBQM) 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 everything you need 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.