From protocol to locked database. One platform.
AI drafts the eCRF from your protocol, sites capture at the bedside, and data cleans as it arrives — so database lock is a milestone, not a scramble. Every stage leaves proof the database itself enforces.
The lifecycle
Capture once. Defend it for years.
Five stages, one system, no re-entry. What happens at each stage is also what makes the data defensible later — the audit trail, the signature hash, the frozen record.
01 · DesignAI drafts configuration from an explicit design brief and approved historical form templates. It never receives historical subject values; a data manager reviews every draft before application.Human-reviewed
02 · CaptureSites enter data online at the bedside. Navigation stays blocked until the server confirms each save, and edit checks run at entry.Confirmed
03 · CleanQueries and source data verification run alongside capture. Only the raiser closes a query, and no one approves their own correction.At entry
04 · Sign & freezeThe investigator e-signs with password re-authentication. The signature binds a content hash, and a database trigger freezes the record — immutability doesn't depend on application code behaving.Provable
05 · Lock & exportCDISC SDTM, ODM 1.3, Excel and CSV are analysis-ready the day you lock — with explicit missing-value reasons, so statisticians start immediately.Analysis-ready
Versioned
from reviewed design draft to immutable published form version
Audited
regulated writes carry actor, time and required change reason
IT · EN
bilingual capture for European sites
SDTM · ODM
plus Excel, CSV and PDF casebooks
Go deeper
The platform, piece by piece.
Inside the EDCEvery module, shipped — AI study design, versioned eCRF designer, queries & SDV, e-signatures, audit trail, exports, randomization, specimen custody, statistics.Modules
Compliance & securityDatabase-enforced isolation, append-only audit trail, AAL2 signatures, signed-record freeze and controlled export receipts.Controls
Integrations & APITime-limited, study-scoped API credentials, CDISC exports and controlled custom vendor interfaces.Developers
See it running
Your protocol, live as a study.
We'll stand up your protocol — forms, visits, sites, roles — and walk your team from first capture to a signed, exportable casebook.