Addressing COVID-19 Specific Regulatory Guidance and Ensuring Early Risk Detection
King of Prussia, PA – August 4th, 2020: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials, today announced the success of its complimentary COVID-19 risk management package alongside comprehensive support for COVID-19 affected trials. Launched in April in the wake of COVID-19, the support package includes a widely used online Risk Assessment and Control solution that can be leveraged for performing risk planning and mitigation activities addressing inherent risks during this crisis.
With sponsors and CROs facing a myriad of new recommendations and guidelines issued by the FDA, EMA, PMDA, MHRA and other local agencies due to coronavirus, the complimentary support package was an indispensable contribution allowing sponsors and CROs to accelerate their response. Many organizations were struggling to keep up with the need to assess and control risk on new and ongoing studies, with documentation and audit trails even more important in this highly dynamic environment. Currently, 183 studies across 22 Sponsor and CRO organizations have taken advantage of the CluePoints COVID-19 support package that was offered for free. CluePoints has been commissioned to provide deeper analytical support to a further 135 studies, allowing regular interrogation of the data to guarantee data quality and integrity at a time when remote monitoring is simply not possible.
Commenting on the support package, Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints said, “The response to our complimentary risk assessment package has been fantastic. It has been an extremely challenging time for clinical trial management, especially with the need to perform risk assessments for each study to identify and mitigate risks pertinent to the COVID-19 crisis. We have also seen a significant increase in existing clients stepping up their data analysis to ensure early detection of issues needing urgent attention. Sponsors and CROs both recognize the benefits of early risk identification and are accelerating the implementation of RBQM solutions to circumvent the challenges of onsite monitoring disappearing overnight. Our solutions are currently being utilized by over 100 sponsors in the context of this crisis, allowing them to focus their attention at the right time on what really matters most to ensure study success.”
One CRO, a global leader in early phase clinical research services, has significantly benefitted from the free access to the CluePoints Risk Assessment tool over the duration of the crisis. The complimentary guidance and solution has been indispensable, helping the CRO to focus on the new COVID-19 specific risks across over 100 of their studies and outlining ways to control identified data discrepancies. Access to simple online eLearning allowed for rapid setup and the support offered via CluePoints Subject Matter Experts (SMEs) ensured rapid onboarding.
At this unprecedented time, CluePoints has been offering support to all operational teams, helping them to manage their studies remotely by interrogating all clinical and operational data. CluePoints solutions have also been utilized in over 12 high-profile specific COVID-19 vaccine studies with leading pharma sponsors in conjunction with their top five CRO development partners. Patrick continued, “We have received some amazing feedback for our COVID-19 support package and are proud to be involved in the fight against this brutal pandemic on some of the leading vaccine trials currently in progress. A huge number of sponsors and CROs are realizing the benefits of our powerful analytics tools at a time when it pays to be disruptive and innovative in the fight to combat a global health crisis.”
As pioneers in the field of RBM, CluePoints is poised to continue to respond to industry demand, ensuring sponsors, CROs and Clinical Technology Partners benefit from constant innovation and transparency. For further information on CluePoints’ solutions, please visit www.cluepoints.com
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.
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Patrick Hughes – Chief Commercial Officer, CluePoints
+44 (0) 7703 532 749