When One Positive Outlier Exposed a Systemic Issue and Protected a Critical Secondary Endpoint

CASE STUDY

In a Phase I neurology study, what looked like a minor data anomaly turned out to be an early warning of a much larger risk, one traditional monitoring approaches failed to see.

CluePoints' Patient-level Data Quality Assessment (DQA) helped the sponsor detect the issue early, take swift corrective action, and protect confidence in the study before timelines, costs, or endpoints were impacted.

This case study shows how modern Risk-Based Quality Management surfaces hidden risks that only emerge when data is viewed holistically.