Why Download this Case Study?
Compelling Evidence on how to Leverage Central Statistical Monitoring to Facilitate Early Risk Detection.
CluePoints is growing an impressive body of evidence reinforcing the value in utilizing Central Statistical Monitoring (CSM) to drive Risk-Based Quality Management (RBQM). CluePoints CSM solution is underpinned by a set of unique statistical algorithms that interrogate clinical and operational data in real-time to conveniently illuminate outliers and anomalies across sites, patients, countries and regions. The adoption of statistics to assist with quality oversight in trials is well-documented. So much so, that the FDA extended its CRADA with CluePoints to further explore a data-driven approach to oversight in clinical trials.
Our latest case study showcases what happened when we retrospectively applied our CSM solution to a completed Sponsor-initiated Phase II Diabetic Kidney Disease trial database. This particular study enrolled over 300 patients across more than 60 sites.
Using Central Statistical Monitoring Found Unknown Serious Data Issues at 20% Study Progress.
Had the CluePoints Solution be utilized during study conduct, the site with significant issues would have been discovered at least 16 months earlier, allowing the team to take corrective action in a timely fashion and preventing potential study failure.
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