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 the eCRF, visit schedule and consent bindings straight from your protocol PDF. A human reviews and approves every change before anything applies — study setup takes days, not months.AI-drafted
02 · CaptureSites enter data at the bedside on iPad — online or offline. Edit checks fire at entry, so cleaning starts the moment data exists.Bedside
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
Days
from protocol PDF to a reviewed, live study build
100%
of writes attributable — actor, time, 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, signature freeze, backups, GDPR-aligned controls, optional blockchain anchoring.Controls
Integrations & APIPermission-scoped REST API, MCP agent interface for AI analysts, CDISC exports, and custom vendor interfaces built on request.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.