CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical trials, has announced it has won, in collaboration with BioNTech and Pfizer, the Clinical Advance of the Year category – COVID-19 Pandemic Special Recognition Award at the 17th Annual Scrip Awards.
The 2021 Scrip Awards was held at the Royal Lancaster Hotel, London, on December 2nd. The award recognizes CluePoints support with BioNTech and Pfizer on their Phase I/II/III study of the SARS-COV-2 RNA vaccine BNT162b2 (Comirnaty). The development program for BNT162b2 encompassed all clinical trial phases I, II, and III into one study to expedite the development and included more than 40,000 participants from a broad range of demographics recruited from 150 global sites.
To process and protect the integrity of the vast volumes of data being generated by the trial, which recruited at a rate of 5,000 people a week, and to counteract the inability to perform on-site monitoring activities due to global infection-control measures, Pfizer worked with CluePoints to deploy an agile, real-time, risk-based monitoring (RBM) approach. Led by a core clinical study team and clinical data scientists, the central monitoring (CM) analytics focused on an evolving set of study-specific key risk indicators (KRIs), data quality assessments (DQAs), and quality tolerance limits (QTLs) delivered through the CluePoints platform. Data was analyzed daily rather than the typical monthly or quarterly review, allowing data quality issues to be identified and rectified in near real-time. In addition, teams were expanded to cope with the additional workload, and global sites worked “in relay” to enable 24/7 centralized monitoring.
BNT162b2 became the first Covid-19 vaccine to receive regulatory approval, just 266 days after the pandemic declaration. As of November 30, 2021, almost 268 million Pfizer-BioNTech COVID-19 vaccine doses had been administered in the US alone.
Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, said, “It is an absolute honor to receive this award that recognizes our pioneering work and emphasizes the value of employing an agile, RBQM approach. This study represents a leap forward in how clinical trials are conducted. Our RBQM approach allowed Pfizer to increase efficiencies to such a level that it submitted drug applications in record time, with very high levels of quality. In addition, it showed that CM analytics can be used to alert the team to sites with high risk – which was particularly important at a time where site monitors were unable to visit sites.”
Hughes added: “Pfizer will take what it has learned from conducting this pivotal trial and apply it to a number of its new compounds that have the potential to tackle unmet medical needs or have a significant positive impact on global healthcare. Patients are waiting for these medications, and with this laser-focused, RBQM approach, science will win.”
CluePoints previously took home the award for best technological development in clinical trials in the 2019 Scrip Awards.