The challenge
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:
- Maintaining motivation and compliance among participants during long, burdensome trials
- Achieving consistent endoscopic image analysis, which can be affected by reader score subjectivity and variable image quality from sites
- Ensuring a coordinated approach between eCOA and imaging data collection strategies, which recognizes interdependencies
A single-vendor approach with an integrated, robust eCOA and imaging solution is a key advantage.
Situation
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 solution
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:
- eDiary with alerts and engagement tools
- Endoscopic video image acquisition, QC and centralized image analysis
- Site training and 24/7 multilingual support
- Integrated Mayo score data and trial oversight in a single portal
Success factors
Clario’s expert-led approach involved:
Single-partner solution
- Standardized, seamless data integration to minimize sponsor burden
- Real-time visibility of Mayo score and trial progress for sites and sponsor on a single portal
Expert UC-specific scientific support
- Expert coordinated team of eCOA and imaging scientists, gastroenterologists and solution design architects
- Guidance for the entire study lifecycle including protocol and diary design, image QC and centralized reading
- Coordinated approach to eCOA and imaging data collection including recognition of interdependencies
Robust, standardized data collection
- Science-led digital eCOA solution with alerts to simplify participation, drive compliance and ensure high-quality data
- High-quality standards and processes for standardized endoscopy video acquisition, QC, site training and centralized analysis
Impact
Study complexity simplified for sponsor
Data collection, integration and reporting from a single partner
Regulatory-compliant clinical data
Standardized, compliant data thanks to Clario’s high-quality standards, processes and devices for data collection
Participant burden minimized
Minimal burdensome assessments and deployment of a user-friendly, intuitive app with built-in engagement features by Clario