Safe AI

AI built for regulated trials.

AI suggests. Your team decides. Everything is recorded.

How AI works in Capture

People stay in charge.

AI does the reading and the first draft. Your team checks it and makes the call.

AI is optional

Use AI only where you want it. Every part of the platform works without it.

AI suggests, people decide

AI can only read and suggest. A person on your team approves and makes every change.

Every change is recorded

Every change is made by a person and kept in the audit trail, with who approved it and when.

Never trained on your data

Your trial data is never used to train AI models.

Isolated AI models

Each AI task runs on its own isolated, open-source model, built for that one job.

Your data stays in your region

Your study data is hosted in the region you choose: US or EU.

What happens when AI makes a suggestion

1

AI reads

AI reads the protocol, a document or your request.

2

AI suggests

It drafts a change or flags a problem for your team.

3

A person decides

Someone on your team approves, edits or rejects it. Nothing changes before that.

Compliance

The same controls as the rest of the platform.

Capture is 21 CFR Part 11, HIPAA and GDPR compliant, and ISO 27001 certified.

  • ISO 27001 certified
  • 21 CFR Part 11 compliant
  • GDPR compliant
  • EU and US data hosting
  • HIPAA compliant
  • ICH GCP E6(R3) compliant

For your QA and security review

Get our validation package and answers to your security questionnaire, including how AI is used.

FAQ

Questions we hear a lot.

Can we turn AI off?
Yes. AI is optional, and the platform works fully without it.
Can AI change our data?
No. AI can only read and suggest. A person on your team approves and makes every change, and it's recorded in the audit trail.
Is our data used to train AI?
No. Your trial data is never used to train AI models.
Where does the AI run?
On isolated open-source models, each built for one task. Your study data stays in the region you choose, US or EU.

Your next trial starts here.

Book a 30-minute demo and see a study like yours built live. Or try the AI Study Builder yourself.