The EDC
One model. One audit trail. From first draft to lock.
Draft, capture, check, sign — the same steps on every study, from build to database lock. The EDC is live today, and it connects once, at its boundary, to the systems you already run.
The Trialion EDC is live today on one data model. It connects across the same boundary to the systems you already run for CTMS, eTMF, eConsent, ePRO / eCOA, RTSM / IWRS, Safety database, Medical coding, RBQM & central monitoring.
The advantage isn't features. It's the shared foundation.
Point tools can each be good. What costs you is everything between them — the integrations, the reconciliation, the seams. Inside the EDC there are none, because there is only one system.
One trial data model
Forms, edit checks, queries, signatures and exports read and write the same subject, visit and form records. The value captured in the eCRF is the value the SDTM export sees — no copies, no sync jobs.
One audit trail
Every action, from a drafted field to a database lock, lands in a single immutable, queryable audit trail. Inspections stop being a scavenger hunt across vendor portals.
One set of roles
A coordinator, data manager or PI is one identity with one permission set, from first entry to lock. Nothing to re-provision per study, and nothing to reconcile between logins.
The parts of the EDC.
Three parts, one product. Each has its own page, and each is live on every study today.
Organised around what a trial actually does.
Every system below is one you already run — your CTMS, your eTMF, your eConsent, your safety database. The EDC reaches each of them across the same boundary: one connection to maintain, not nine contracts to sign.
Fewer moving parts, lower total cost.
The licence is not what a legacy stack costs you. The integration, the reconciliation and the overhead between the pieces are.
| Legacy stack | Trialion | |
|---|---|---|
| Data residency | Wherever the vendor hosts | DPDP Act 2023 aligned |
| Information security | Varies by vendor | Encrypted, role-based, fully logged |
| Bioequivalence templates | Build from scratch | Pre-built, replicate-design ready |
| Study build | Weeks of form programming | Drafted from the protocol, approved by a person |
| Source data entry | Typed from the PDF, then verified | Read by AI Capture, confirmed by a person |
| CDSCO submission pack | Manual assembly | Generated from the data model |
| Remote site connectivity | Paper + transcription | Mobile-first offline capture |