Early-access program
Early-access teams building faster, with fewer downstream fixes
Clinical data management teams and CROs in early access have measured meaningful cuts in setup time and post-enrollment amendment frequency.
Early team findings
Measured results from pilot builds
Metrics come from internal early-access pilots tracking build time and amendment frequency; results varied with protocol complexity.
Veritas Clinical Research: 9-week EDC build reduced to 2.5 weeks
The challenge
A Phase II oncology study with multi-arm design, response endpoints, and adaptive dose escalation needed a complete Medidata Rave EDC build. Manual work, including CRF design, edit check setup, and sponsor review cycles, was estimated at 9 weeks.
The result
Concordare parsed the 142-page protocol and produced a complete Rave builder XML export in 48 hours. The data management team reviewed parsed elements for 2 days, made targeted variable-naming adjustments, and loaded the sponsor environment within 2.5 weeks of protocol receipt.
Halcyon Therapeutics: adaptive endpoints structured without manual mapping
The challenge
A rare disease protocol with adaptive endpoint definitions, patient-reported outcome instruments, and an extended 24-month follow-up required precise CRF mapping. The sponsor expected 6-8 weeks of clinical data manager time to configure the Veeva Vault EDC study design.
The result
Concordare mapped the branching endpoint logic and PRO instrument collection schedules correctly. The generated Vault EDC export preserved the adaptive structure without manual intervention. After 2 days of review, the team approved loading within the first week after protocol receipt.
Study team voices
From data managers and operations leads
"We had a 9-week EDC timeline for a Phase II oncology study. Concordare cut the initial build to under two and a half weeks. The parsed structure matched our protocol intent with fidelity that surprised our data managers."
"Our rare disease protocol included adaptive endpoint definitions that I expected to take weeks of CRF mapping. Concordare handled the branching logic correctly. We spent two days reviewing rather than two months building."
"Protocol version tracking changed our amendment process. We can identify exactly which database elements each amendment affected without a full re-review of the entire build."
Join our early-access program
We are accepting a limited number of new teams. Request access for a build estimate on your next protocol within 48 hours.