- Case Study
Catching the Unseen: How a Top 50 Sponsor Uncovered Data Manipulation with Centralized Statistical Monitoring (CSM)
What If You Missed a Red Flag?
When a Phase II Cardiovascular & Metabolic study showed suspicious creatinine clearance values at one center, an audit confirmed data manipulation. Despite applying centralized monitoring techniques, the Sponsor’s existing platform couldn’t flag the issue in time.
To uncover what went wrong (and how it could’ve been caught earlier), the Sponsor turned to CluePoints’ Central Monitoring Platform (CMP). The challenge was structured in two phases: first, to see if CluePoints could detect the issue in a completed study without prior knowledge, and second, to evaluate just how early the problem could’ve been identified using Data Quality Assessment (DQA). The results? Eye-opening. Explore how a proactive, data-driven approach to CSM revealed what traditional methods missed.
