Case In Point
Strong DMC Management for Renal and Cardiac Studies
About Client
The client is a sponsor in need of DMC management and statistical support for two clinical studies in its renal program. The studies included a Phase III renal study and a Phase II renal/cardiac study, involving more than 500 total subjects.
Study #1: Phase III renal study with ~250 subjects treated and followed for 1 year.
Study #2: Phase II renal and cardiac study with ~260 subjects treated and followed for 4 months.
Challenge
- Study #1 was already ongoing when Everest was engaged, requiring a smooth transition of Data Monitoring Committee (DMC) management and related study activities
- A need for consistent DMC oversight across two studies with overlapping team membership but distinct protocols
- DMC operations required structured coordination and timely data delivery across two timelines and therapeutic areas
Solution
Everest provided full DMC administration and statistical support for both studies. Services included:
- For Study #1:
- Took over DMC management mid-study
- Implemented a new DMC Charter, developed a new membership roster, and created a DMC data analysis and reporting plan
- For Study #2:
- Supported DMC activities from initial start-up
- Developed a separate DMC Charter for this study
- Operational Approach:
- The same members served on both DMCs, but each study had its own charter and independent structure
- DMC meetings occurred every 3 months, alternating between the two studies (each study reviewed every 6 months)
- Data reports included executive summaries and were delivered in a timely manner for committee review
Results
- High-quality deliverables were consistently provided
- The timely delivery of DMC reports ensured effective and regular safety reviews
- The client benefited from smooth transitions, structured planning, and consistency across both studies
