AI Study Builder

The AI Study Builder helps you design and configure clinical studies directly in Ledidi, within GCP guidelines. Upload your protocol and the builder drafts the structure: visits and visit windows, unplanned events, the forms attached to each of them, and participant-reported surveys. Your team reviews and has full control over what goes live. Built for research teams and CRO study managers rather than programmers.

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How it works

Upload your protocol

Upload your protocol or explain your study in plain language: the design, the intervention, the follow-up schedule and what you need to collect.

Review the structure

Visits, visit windows, forms, unplanned events and participant surveys are drafted as editable Ledidi objects. Keep what works, change the rest.

Approve and publish

Nothing is published until you approve it. The study is then configured in Ledidi and ready for sites, coordinators and participants.

What the builder sets up

Each item is created as an editable object in your study, not a document you then have to build from.

Visits and visit windows

Screening and baseline, plus follow-ups scheduled relative to an intervention date, each with its own window.

Unplanned events

Adverse events, SAEs and other event-driven records that sit outside the visit schedule.

Forms on every visit and event

Fields, value ranges and validation, attached where they belong and editable throughout.

Participant surveys

Patient-reported outcomes configured on their own schedule and sent to participants directly.

The builder proposes. Your team decides.

AI in a regulated study only works if a qualified person can see what it did and say no. Every suggestion is reviewable, editable and attributable before it affects data collection.

Review before publish

No generated visit, form or survey becomes part of a live study until someone approves it.

Editable, not final

Everything the builder creates is an ordinary Ledidi object. Rename it, restructure it, delete it if needed.

Full audit trail

Configuration changes are logged with user, timestamp and before/after state, the same as any other action in the platform.

Built for GCP

The build process is designed to fit GCP expectations and FDA 21 CFR Part 11 controls.

Security and data handling

The builder works on study design and runs under the same controls as the rest of the platform.

No training on your content

What you enter in the builder is not used to train public models.

Study design, not patient data

The builder does not have access to any participant data.

Certified infrastructure

ISO 27001 certified, GDPR and HIPAA compliant, processed with confidential computing.

Documented for review

Security documentation is available through the Ledidi Trust Centre and release and validation documents are available in-app.

What our clients say

Hania K
Regulatory Affairs Specialist,
PBC Biomed

"I have been very impressed with the Ledidi platform, particularly the AI Study Builder functionality, User interface, and automated scoring capabilities. I would also like to highlight the speed of the process, we were very pleased that we were able to complete the study setup within the platform quickly and efficiently, thanks to the excellent support and responsiveness of the Ledidi team."

Start building your next study today

Set up visits, forms, events and participant surveys with the AI Study Builder, review everything with your team, and publish when it is right. Start a 30-day trial or book a personalised demo with our clinical team.

Start 30-day trial

Schedule a demo