How ClinicAI works.

Four steps from raw chart to clean EDC entry. The AI does the reading and drafting. Only a reviewer can move data into your regulated system.

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The AI reads. A person decides.

  1. Upload recordsClinicAI

    PDF exports, CCDA files, scans and faxes. Whatever format your sites send.

  2. AI extractsClinicAI

    Pulls the data points your CRF requires, each with a confidence score and a source citation.

  3. Reviewer verifiesYour team

    Accept, edit or reject each field with the source passage highlighted beside it.

  4. Transfer to EDCYour team

    Export in CDISC format or enter into Rave, Vault or InForm. The full audit trail comes with it. ClinicAI never writes to your EDC.

Built around 21 CFR Part 11 from day one.

Designed for the questions your quality team will ask, instead of retrofitted to answer them.

21 CFR Part 11 alignedCDISC exportRole-based accessEncrypted at rest and in transit

Human in the loop

The AI drafts. A reviewer approves. Nothing AI-generated enters your EDC without an explicit human sign-off.

Complete audit trail

Every suggestion, edit and decision is logged with a timestamp and user ID, ready to export for inspection.

Separate staging layer

ClinicAI mirrors your EDC structure but is never the regulated system, keeping a clear line between draft and record.

Source citations

Every value links to the exact passage it came from, so a monitor or inspector can trace any data point to its origin.

Read the full compliance architecture

See ClinicAI on your own protocol.

We're onboarding pilot customers now. Send us a protocol and a sample of de-identified records, and we'll show you the extraction.

Request pilot access