CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials, announced the launch of its new business intelligence platform, BEYOND. Designed to encompass more than just early risk detection, this extended visualization solution takes CluePoints beyond the interrogation of data and allows Sponsor and CRO users to explore areas of interest in one integrated business intelligence system. The powerful analytics tool allows users to confidently certify the quality and integrity of data whilst ensuring patient safety and regulatory compliance. Learn how the BEYOND business intelligence platform can help you reach your clinical trial goals here.
Francois Torche, Co-Founder & Chief Executive Officer of CluePoints comments, “We are very excited to launch our novel business intelligence platform as an extension of our ongoing commitment to helping companies identify, assess, plan, mitigate, monitor and analyze risk across all elements of clinical trial management. It is a key milestone in our strategy to become a knowledge company and we would like to thank those sponsors who have collaborated to bring this vision to life.”
As the industry realizes the benefits of Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM), users are looking for ways to extend the way they drill-down into risks and focus on what matters most within their studies. The comprehensive nature of the analytics offered within this novel business intelligence platform gives all users the data exploration tools and personalized visualizations they need to test hypotheses and drive critical thinking. Within one unique platform, risk signals can be identified, and an embedded Issues and Actions Management system ensures that all evidence is fully documented and accessible. This guarantees full compliance with ICH E6 (R2) and other global regulatory requirements throughout the lifecycle of the clinical trial.
Francois continued, “It facilitates a deeper understanding of what’s happening within a trial, whether that’s focusing on a specific area of the clinical trial, such as the Safety Profile and the status of Adverse and Serious Adverse Events; wider focus on clinical data such as plotting vitals and lab results and exploring connected data, tracking enrollment and screen failures or even looking at the operational data in a trial, such as missed assessments or query turnaround.”
As pioneers in the field of RBM, CluePoints are poised to respond to industry demand, ensuring sponsors, CROs and Clinical Technology Partners benefit from constant innovation and transparency. This all-encompassing platform offers an exclusive combination of both supervised and unsupervised data surveillance techniques that enables users to test what they think they know, as well as what they could not possibly know or suspect. The ability to select or create the appropriate visualization to explore that data in its most powerful format offers actionable insights across safety, clinical, enrollment and operational aspects. Combining business intelligence, analytics and reporting in one platform enables greater knowledge sharing for data-driven success.
CluePoints is the 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 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.