Many sponsors. One EDC. Zero data bleed.
We are a CRO ourselves — this is the multi-sponsor platform we needed: isolation the database enforces, duties the system separates, and study builds that take days.
A CRO's EDC problem is not one study — it is twenty studies for eight sponsors, each with its own sites, roles and monitors, on one platform where nothing may ever leak between clients. Isolation cannot be a convention your developers remember; it has to be a property of the system.
Isolation the database enforces
Every request runs inside a per-tenant database transaction under row-level security. A connection without a tenant context reads nothing — including raw queries. Sponsor A's monitors can never see sponsor B's subjects, and you can demonstrate that to a client in the running product, not in a slide.
Duties the system separates
- Roles are per-study and per-site, built from a permission matrix of 20+ rights (SDV, unblinding, exports, role management…). Each client can have its own custom roles; a role can never be edited into a lock-out.
- Query segregation is enforced, not advised. The person who opened a query cannot approve or reject it; when a data edit moves a query to "awaiting approval", the editor cannot approve their own correction — the server refuses.
- Verification cannot go stale. Editing a source-verified value, or querying it, automatically voids the field's SDV and the form's — the monitor re-verifies exactly what changed.
- Risk is watched per site: open queries per subject, query resolution days, overdue visits, data changes per form, SDV coverage and signature rate — each banded against the study mean ± SD, so a drifting site stands out before a monitoring visit.
Stand up studies in days
A new study is configuration, not a project: register sites (each with its own subject-numbering scheme), let the AI assistant draft the eCRF and visit schedule from the protocol PDF, review, publish. Published form versions are immutable snapshots — subjects captured on v1 stay on v1 when v2 ships, so every study remains reproducible. Daily e-mail digests chase overdue visits, unanswered queries and unsigned forms so your CRAs don't have to. When a sponsor brings their own LIMS, safety database or statistics pipeline, our team designs and builds the interface with you.
The result: more studies per data manager, cleaner handovers to biostatistics, and an audit posture you can show — not describe.