CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials, today announced that its Risk-Based Quality Management (RBQM) platform has been critical in supporting numerous Pharmaceutical companies and CROs to interrogate data in their global COVID-19 vaccine and antiviral antibody trials to ensure data quality and integrity.
CluePoints played an important role in one of the largest of these vaccine trials which was conducted across several hundred sites and multiple countries, including most US states, and recruited tens of thousands of trial participants. The size, magnitude and critical importance of this study required a robust RBQM platform to drive regular assessments of quality, across a volume of clinical and operational data, that has accrued at unprecedented rates. The CluePoints software, which saw a rapid implementation time of only two weeks, allowed the client to monitor and analyze the trial data in near real-time, across all the participating sites and countries. Focusing on speed, accuracy and reliability, this mitigates risk to both patient safety and to the integrity of the study data, alleviating potential critical delays in final regulatory submissions at such a significant time for the global health crisis.
Vaccines are a critical part of addressing this pandemic to decrease rates of infection, disease and death worldwide. By partnering with various industry vendors, including CluePoints, this Pharmaceutical company has leveraged decades of scientific expertise to formulate, test and manufacture an mRNA vaccine to help prevent COVID-19 in perhaps the fastest vaccine trial ever conducted.
Commenting on the collaboration, Patrick Hughes, Co-Founder and Chief Commercial Officer at CluePoints said, “We are delighted to see that our collaboration on such momentous and exciting studies is having such a positive impact in ensuring successful approvals. Never has it been more crucial to ensure that such important studies are executed without delay and are free from any data quality and integrity issues. These sponsors and CROs required an innovative and proven approach to support early risk detection, which is exactly what CluePoints’ software is designed to do. For CluePoints to be able to support studies of this magnitude, in record time, is testament to the responsiveness, flexibility and efficiency of all stakeholders involved in these partnerships.”
CluePoints’ RBQM platform is used to detect and monitor any potential risks as early as possible allowing corrective action to be taken at record speed. Teams can access information centrally, collaborate and document mitigations and remedial actions to produce a clean data set and prepare for the usual regulatory scrutiny. This assurance of quality and integrity of the data could not have been achieved with this rigor in these timelines using only traditional site monitoring methods on a study of this size and scale.
CluePoints has been committed to supporting its clients throughout the pandemic, providing software and assistance on a number of COVID-19 studies, in addition to supporting studies directly impacted by COVID-19 restrictions and regulations. CluePoints introduced a dedicated COVID-19 package that incorporates a specific Coronavirus-specific Risk Assessment template that includes a set of relevant risk categories and associated considerations gleaned from regulatory guidance documents issued by FDA, EMA, PMDA and MHRA. The team has also offered extensive guidance on how Central Statistical Monitoring provides a credible remote monitoring support solution. There has been a dramatic increase in demand for remote and centralized site monitoring amid the ongoing Coronavirus outbreak.
Hughes continued, “Across the clinical trials industry, every effort is being made by CROs and Pharmaceutical companies to achieve unprecedented progress with vaccine trials and other COVID-19 treatments. The ability to quickly prove that therapies are safe and effective for regulatory review dramatically accelerates availability of novel medicines. Data quality and early risk detection is crucial to support the pace of such programmes and to achieve high efficacy treatments which can be made widely available in the shortest time. CluePoints’ best-in-class solutions have been selected by several leading sponsors and CROs to ensure that no stone is left unturned in mitigating risk and maintaining the highest data quality and integrity during accelerated drug development processes. We are seeing more COVID-19 studies starting in the first quarter of 2021 and are delighted and privileged to continue to play our part in the quest to find a range of vaccines and treatments to ultimately conquer the spread and seriousness of this abominable pandemic.”
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.