Risk Planning Guidance Addresses FDA, EMA, PMDA and MHRA Coronavirus Advice
King of Prussia, PA – April 06, 2020: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials, today announced that it has launched a complimentary COVID-19 risk management package and template available to all at no cost. With the FDA, EMA, PMDA and MHRA issuing specific guidelines as a result of the coronavirus, the CluePoints package will help meet these new recommendations and address additional study risks. The platform 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. Register here for the COVID-19 risk management package.
Many clinical trials are facing key challenges, including an increase in missed patient visits, missed assessments, missed study treatments and increased dropouts. Studies are encountering IP supply chain disruptions, recruitment issues and slower site responsiveness. There are gaps in reporting adverse events, less frequent interactions with patients and reduced on-site monitoring visits. The relative scope and impact of these common risks will vary by study, as will the proposed mitigations.
Additional study-specific risks need to be addressed and the regulatory bodies recommend that a fresh risk assessment is performed for each study to identify and mitigate risks pertinent to the COVID-19 crisis. The CluePoints COVID-19 package incorporates a special coronavirus-specific Risk Assessment template that includes a set of relevant risk categories and associated considerations gleaned from the regulatory guidance documents issued by FDA, EMA, PMDA and MHRA. The increased threat of Coronavirus infection may pose a particularly high risk for certain patient populations and/or study treatments (e.g., studies testing immunosuppressant therapies). Further, CluePoints provides recommendations regarding risk controls in the form of specific COVID-19 Key Risk Indicators (KRIs) and will assess each study position before offering advice.
Commenting on the current situation, Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints said,“In the wake of COVID-19, we are hearing that many Sponsors and CROs are struggling to keep up with the need to assess and control risk on new and ongoing studies , with documentation and audit trail even more important in this highly dynamic environment. We currently have over 50 requests from sponsors and CROs to help them implement COVID-19 specific risk management ASAP and over 400 have wanted to hear more about the free offer. At this unprecedented time, we are delighted to play our part by helping all operational teams to manage their studies remotely by doing what we do best, interrogating clinical and operational data in a completely unsupervised fashion.”
The complimentary risk assessment package includes:
- Free access to the CluePoints Risk Assessment Categorization Tool (RACT) for the duration of the crisis
- Complimentary guidance supporting users to focus on the new COVID-19 specific risks that are likely evident in most studies and how to control them
- Access to simple online eLearning (30 mins) to allow rapid setup
- Support via CluePoints Subject Matter Experts (SMEs) to facilitate onboarding
Hughes continued, “As pioneers in the field of RBM we are able to help, which is why we are offering this package free of charge. We are committed to our clients, and will do all we can to ensure sponsors, CROs and Clinical Technology Partners benefit from constant innovation and transparency.”
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 – Co-Founder and Chief Commercial Officer, CluePoints
+44 (0) 7703 532 749