Assessing disease severity in ulcerative colitis trials is complex, and ensuring standardized, compliant data collection and seamless integration across eCOA and imaging components is challenging.
Specific challenges include the following:
A single-vendor approach with an integrated, robust eCOA and imaging solution is a key advantage.
A European sponsor was performing a three‑year ulcerative colitis study with over 300 participants. This study took place in sites across North and South America, Europe and APAC. Clario was engaged to collect remote and in-clinic eCOA and endoscopy imaging primary endpoint data. The data collected was used to assess drug efficacy and for participant eligibility.
Clario provided an integrated eCOA and imaging solution to simplify data collection, integration and reporting for the sponsor.
Clario’s consultative, science-led approach included the following:
Data collection, integration and reporting from a single partner
Standardized, compliant data thanks to Clario’s high-quality standards, processes and devices for data collection
Minimal burdensome assessments and deployment of a user-friendly, intuitive app with built-in engagement features by Clario