AI clinical trial platform for biotech teams

Run your clinical trial with AI.

Upload your protocol and AI builds your study in seconds. Run the whole trial in one place, from EDC and ePRO to randomization and drug supply. AI suggests, your team approves.

30-minute demo: we build a study like yours, live.

21 CFR Part 11 · ISO 27001 · HIPAA

Seconds
Protocol to built study
One platform
Every module, one login
Setup
Included

Built for clinical operations teams at biotech and pharma companies

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

Why now

Clinical trials still run on manual work. AI can now take it on.

Building the study, checking data against source documents and the daily admin take weeks of your team's time. Capture's AI takes on that work, and your team stays in charge.

The old way

With Capture

Weeks of manual study build
AI builds your study from the protocol in seconds
Data errors found late, at monitoring
AI checks source documents against your data as it comes inEarly access
Hours of clicking to change forms, set up sites or build reports
Just ask AI, in plain wordsEarly access
Separate vendors for EDC, ePRO, eConsent, randomization and drug supply
One platform, one login
Months before you can even try it
Free sandbox today

Industry average to build and release a study database: 68 days (Tufts CSDD, 2017).

What AI does for your trial

AI that builds, checks and manages your study.

1 · Build with AI

Upload your protocol. AI builds the study in seconds.

No more weeks of manual setup. Capture's AI reads your protocol and builds the full study. Your team reviews it, changes anything, and approves it before go-live.

  • Visit schedule and data forms (eCRFs)
  • Randomization and patient questionnaires (ePRO)
  • Online consent forms (eConsent)
  • Review, edit and approve every form yourself
2 · Check with AIEarly access

AI catches the errors your edit checks miss.

Upload a lab report, photo or scan. AI reads it, compares it with what was entered, and flags anything that doesn't match, with a query ready to send to the site.

  • Reads PDFs, photos and scans
  • Flags values that don't match the source document
  • Sends a query to the site in one click
  • Fills in forms from the document
3 · Manage with AIEarly access

Manage your study by asking, in plain words.

Change forms, set up sites and users, or pull a report by asking AI, instead of clicking through menus. Built to work with the AI tools your team already uses.

  • Edit forms and visits
  • Set up sites, users and settings
  • Pull reports and status updates

All on one compliant platform: EDC, ePRO, eConsent, randomization, monitoring, safety reporting and CDISC exports.

Safe AI

AI built for regulated trials.

AI suggests. Your team decides. Everything is recorded.

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.

How we keep AI safe

How it works

Step 1

Upload your protocol

AI builds the study in seconds.

Step 2

Review and test

With your team, and your CRO if you use one. Change anything yourself, with setup help included.

Step 3

Go live and run it

Enroll participants and collect data. Use AI to check it against source documents (early access).

Easy and safe to start.

Start with a pilot

Try Capture on your next study, or one part of it, before you commit.

Your data is yours

Export everything at any time: CDISC SDTM, CSV and Excel.

Validation and security on request

Get our validation package and answers for your security review.

Setup included

Our team helps configure your study, with you or your CRO.

Enterprise plans for pharma and multi-study programs

FAQ

Questions we hear a lot.

Can our CRO use Capture?
Yes. Your CRO can run the study on Capture with role-based access, and your team sees the same live data.
Who sets up the study?
You can build it yourself with the AI Study Builder, or our team configures it with you at no extra cost.
How long until we can go live?
AI builds the study in seconds. Going live depends on your review, testing and approvals, and our team helps you get there.
Is this validated for regulatory submissions?
Yes. Capture is 21 CFR Part 11 compliant, with electronic signatures, audit trails and role-based access. A validation package is available.
Is AI safe to use on our trial data?
Yes. AI is optional, it can only read and suggest, and a person on your team approves every change. Your trial data is never used to train AI models.
What happens to our data if we stop using Capture?
Your data is yours. You can export everything at any time as CDISC SDTM, CSV or Excel.
How is my data secured?
Encryption at rest and in transit, HIPAA-compliant infrastructure, ISO 27001, and hosting in the US (N. Virginia) or EU (Frankfurt), chosen per study.
What does it cost?
Pricing is published on our pricing page, including Enterprise plans for pharma and multi-study programs. Setup is included.
Can I manage my study with AI?
We're opening early access for teams who want to edit forms, set things up and pull reports by asking AI. Join the early access list.

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.