CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical trials, has announced a significant milestone: they have de-risked over 1000 clinical studies.
With over 6,000 platform users and more than 100,000 issues detected, CluePoints is proud to have been an integral player in the adoption of Risk-Based Monitoring (RBM) and later RBQM since the US Food and Drug Administration (FDA) first recommended its use in 2013. Having recently celebrated its tenth anniversary, the company has grown from strength to strength. More recently, its 200-strong team was pivotal in providing Risk-Based Quality Management (RBQM) software to support a number of COVID-19 vaccine and mRNA trials, including the first COVID-19 vaccine to receive regulatory approval within 266 days of the pandemic declaration.
Patrick Hughes, Chief Commercial Officer and Co-Founder at CluePoints stated: “This milestone demonstrates the industry’s ever-growing adoption of data-driven RBQM, reinforcing that this approach is the future of clinical trial oversight and management. With each advancement of the ICH regulations, there has been a growing insistence on the requirement for Sponsors and CROs to adopt risk-based approaches over traditional inefficient techniques, such as Source Data Verification (SDV) and other manual processes.”
CluePoints’ RBQM platform is used to detect and mitigate 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 ultimately produce a clean dataset of the highest quality and integrity faster than ever before.
