RISK MANAGEMENT SOLUTION ADDRESSES FDA, EMA, PMDA & MHRA CORONAVIRUS ADVICE
King of Prussia, PA – May 07, 2020: CluePoints, the premier provider of Risk-Based Quality Management (RBQM) and Data Quality Oversight Software for clinical trials, today announced that its recently launched complimentary COVID-19 risk assessment package and Data Surveillance solution is being utilized in over 200 ongoing studies that are directly affected by Covid-19. The platform, which includes an online Risk Assessment, Risk Mitigation and Data Surveillance solution, is being used to identify, mitigate, resolve and document inherent study risks during this crisis. CluePoints is also analyzing data from several vaccine studies across Europe and North America that are targeting Covid-19.
Addressing the specific recommendations issued by the FDA, EMA, PMDA and MHRA, the CluePoints Covid-19 support package incorporates a focused coronavirus-specific Risk Assessment template that includes a set of relevant risk categories and associated considerations gleaned from the various elements of regulatory guidance. The risk management package includes complimentary access to the CluePoints Risk Assessment Categorization Tool (RACT) for the duration of the crisis alongside a free template to guide users through the new Covid-19 specific risks that are likely evident in most studies. Users also have access to simple online eLearning to allow rapid setup and support via CluePoints Subject Matter Experts (SMEs) to facilitate onboarding. Further, the Data Surveillance tool is helping sponsors and CROs to ensure that no stone is left unturned in identifying and resolving key risks whilst maintaining oversight with new Central Monitoring processes.
CluePoints is already supporting over 50 Covid-19-specific study risk assessments inside the platform. In addition, the team have deployed Covid-19-specific Key Risk Indicator (KRI) dashboards on numerous in-flight trials to enable users to:
- Add KRIs as needed to focus on important Covid-19 emergent risks, such as those related to missed visits/assessments, missed study treatments, and early terminations.
- Leverage optimized KRI designs to enable rapid detection of issues emerging specifically during the Covid-19 crisis period.
- Implement time-window adjusted absolute risk thresholds on KRIs specific to the Covid-19 period.
The Covid-19 package is helping clients to identify, mitigate and control key common risks across studies, any additional study-specific risks, and prioritize by focusing first on studies with upcoming reporting milestones and/or database locks. The CluePoints Data Surveillance solution – which provides advanced KRIs, QTLs, statistical data monitoring, and data visualizations – is giving clients confidence in their ability to effectively monitor their studies even with the current gaps in on-site monitoring.
Commenting on the platform, Patrick Hughes, Chief Commercial Officer of CluePoints said, “Sponsors and CROs are having to adapt quickly in the wake of Covid-19. Assessing risk on new and ongoing studies is a challenge. In a sea of non-compliance, it is important to focus on what matters most – the critical risks and critical data, including incremental versions of KRIs and QTLs. Risk assessment and central monitoring is doubly important during the Covid-19 crisis. The ability to quickly implement a Covid-19-specific risk management solution is offering the industry assurance that key risks can be identified, mitigated and addressed and monitored centrally with confidence.”
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