Draft with AI. Analyze with AI. Integrate with anything.
The EDC is open on both ends: AI accelerates study setup and analysis, and a permission-scoped API moves your data to the systems — and vendors — you already work with.
From approved configuration patterns to a reviewed study draft.
The assistant receives an explicit design brief and up to three independently approved configuration-only templates. It drafts CRFs, visits and consent bindings for a data manager to review; nothing is applied automatically.
The AI route has no query path to subject records, CRF values, safety events, queries, attachments, signatures or audit records. Approved non-AI systems can use time-limited, read-only and study-scoped REST credentials; every call remains subject to RBAC, row-level security and audit attribution.
# authenticated by an issued token — acts as your user $ edc subjects --study 2025HZ001 --site GE-GAL A005 enrolled 88% A006 enrolled 100% e-signed A007 screening 41% 1 query $ edc query open A007 --field temp \ --text "Confirm 38.4 °C — outside range" ✓ query #1180 opened ↳ recorded in audit_log, attributed to you
Lock the database. Start the analysis the same day.
The point of an EDC is what comes out of it. Every export is tidy, coded, and standards-shaped — so your statisticians and data scientists start from clean tables, not from cleaning.
CDISC SDTM & ODM, Excel, CSV
Domain datasets for submission work, ODM XML for archival and system-to-system interchange, real Excel workbooks and CSV for everyone else.
- Explicit missing-value reasons — “not done” never reads as a gap
- Print-ready PDF casebooks per subject
IVD statistics built in
Method comparison runs inside the platform, on live data: bias, Bland–Altman limits of agreement, robust regression, PPA/NPA/OPA with confidence intervals.
- Acceptance criteria scored at entry (ISO 17593-style)
- Key risk indicators per site, continuously
Integrity travels with the data
Exports are permission-scoped and logged; signed records carry a content hash that can be re-verified independently of the application.
- Every export attributable — who, what, when
- Server-generated export receipts with SHA-256 digests
Name the system. We build the interface.
Already committed to a LIMS, a safety database, a statistics platform, or a sponsor portal? Tell us which. We design the interface with you — mapping, transport, and validation evidence — and ship it as part of your study setup. That's what having the development team behind the product means.
Bring your protocol and your toolchain.
We'll connect the two — and your data will arrive where it's needed, analysis-ready and fully attributable.