A validated clinical database, live in weeks — not quarters
We build, configure, and validate your clinical EDC on TrialKit or your existing platform, then hand you a Part 11- and GCP-ready database your team can trust from first-patient-in.
What we do
An EDC platform is only as good as its build. CDMP takes your protocol, schedule of assessments, and edit-check logic and turns them into a fully specified, tested, and documented study database. Every screen, derivation, and validation rule is traceable back to the protocol and forward to your CDISC deliverables — so the database you go live with is the database you lock.
We work natively in TrialKit for fast, cost-efficient builds, and we configure and validate legacy and enterprise environments where your program already lives: Veeva Vault CDMS, Medidata Rave, Viedoc, Oracle Clinical / InForm, Castor, and Medrio. You keep platform choice; we bring the operational discipline.
What's included
- Database design & specification: annotated CRFs, edit-check specifications, and data validation plans mapped to the protocol.
- eCRF build: forms, visits, dynamics, and skip logic configured for the schedule of assessments.
- Edit-check & derivation programming: automated cross-form and range checks, plus derived variables for review.
- User acceptance testing: scripted UAT with documented evidence and defect resolution.
- Validation package: 21 CFR Part 11 and GCP-aligned documentation — IQ/OQ/PQ evidence, traceability matrix, and release sign-off.
- Role & site configuration: user roles, permissions, and site provisioning ready for activation.
- Mid-study changes: controlled amendment handling with impact assessment and re-validation.
Platforms we support
TrialKit · Veeva Vault CDMS · Medidata Rave · Viedoc · Oracle Clinical / InForm · Castor · Medrio. Migrating between any of these? See Database Rescue & Migration.
Why it goes faster with CDMP
The same team that builds the database also runs study conduct and programs your CDISC datasets. Decisions that normally bounce between a technology vendor, a data management CRO, and a biostatistics group happen in one conversation — which is how go-live lands in 1 to 4 weeks instead of a quarter.
Related services
Ready to scope your build?
Send us your protocol synopsis and target platform. You'll get a fixed-fee proposal and a realistic go-live date — in minutes, not RFP cycles.