CluePoints, a company that specializes in risk-based study and data quality technology for clinical trials, has launched its Beyond business intelligence platform. The platform is designed to offer early risk detection and extended data visualization.
According to the company, the Beyond technology enables sponsors and clinical research organizations (CROs) to delive into a number of different areas from one integrated platform. Its analytics capabilities reportedly enable users certify the quality and integrity of data while at the same time guarding patient safety and ensuring regulatory compliance.
Outsourcing-Pharma spoke with Patrick Hughes, CluePoints cofounder and chief commercial officer, who said Beyond combines a number of sophisticated risk-detection in a single solution, enabling users to gain maximum value from clinical and operational data.
“The solution provides regulatory coverage for new requirements within ICH E6 (R2) and the complete process for the planning, identification, evaluation of clinical trial risk, the subsequent discovery and management with communication across the study team, and final documentation of all risk exposed and what an organization did about them,” he said.
Additionally, Hughes explained, Beyond combines a range of methods for risk detection for maximum effectiveness and flexibility.
“The combination of both supervised and unsupervised techniques for risk detection provide the user with the most comprehensive and sensitive environment for exposing issues, leading to higher quality outcomes across all the data collected within the trial. Underpinning all these techniques is a rich data visualization environment that provides data insights and data summarization to all the relevant stakeholders,” he said.
Francois Torche, CEO and co-founder of CluePoints, said the Beyond platform enhances the company’s solutions for clinical trial advancement.
“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,” Torche said. “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.”
Additionally, Hughes told us, risk-based monitoring (RBM) offers clinical trial teams a greater degree of data reliability.
“Risk-based monitoring implements targeted techniques that are more reliable in risk detection and more likely to uncover clinical trial risks sooner than traditional techniques (sending monitors to site to perform 100% SDV results in less than 1% of data changing and to a lot of people is worse than useless as it doesn’t effectively uncover the inherent risks that are present),” he said. “This targeted approach is a more efficient and a less costly approach to monitoring clinical trials that also frees up resources engage with the site and higher value activities, fostering a stronger sponsor–site relationship.”
Torche 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.”
Hughes also told us the Beyond platform provides sponsors and CROs with an easy-to-manage way to explore and manage data, using visualization to simplify processes.
“Beyond provides a quick and convenient way to explore the data being collected and to validate the scope of impact as well as confirm potential hypotheses as to what has caused the risk emerging in that part of the trial. The highly visual nature of Bdyond makes it a perfect self-service solution to get answers from the data quickly, without having to ‘dig’ into data listings or ask other stakeholders to provide the necessary summaries for you,” Hughes explained.