No Trial Is Too Small to Fail…
When a celiac disease pilot study adopted RBQM and centralized monitoring, anomalies at two participating sites were quickly surfaced. Within the first five months, CluePoints’ Central Monitoring Platform (CMP) helped identify missing gluten detection tests and misclassified adverse events, each of which could’ve compromised study success if left unchecked.
Despite the study’s small scale, comprising fewer than 50 subjects and 10 sites, CMP uncovered issues that even traditional oversight might have missed. The Sponsor’s goal: proactively surface risks, course-correct early, and ensure high data integrity across all sites.
So, how did centralized monitoring stack up? And just how early could the issues have been detected without manual data review? Let’s dive into the data-driven story.