Tool profile
Ledidi: cost, fit and limits
Ledidi is a clinical data platform made by Ledidi AS of Oslo that supports registries, audits and research projects, and offers a Trials module for setting up and running clinical studies. Its AI Study Builder reads an uploaded protocol and drafts the visit structure, forms and participant surveys for a team to review.
What to know first
Ledidi sells subscriptions by the year for registries and research, and prices clinical trials separately per study. A solo researcher can start at €360 a year, while a Basic Trial for up to 50 participants and 3 sites costs €9,500 for twelve live months. A 30-day trial runs on the Team plan with a training mode for building studies. The AI Study Builder is listed under Trials, but the pricing page does not say which plans include it.
Ledidi at a glance
| Maker | Ledidi AS, Norway |
|---|---|
| Free plan | Free trial only |
| Entry price | €360 per year for Individual |
| API access | Yes |
| Category | Best AI Clinical Trial Software in 2026, rank 1 of 11 |
| Website | ledidi.com |
Who Ledidi is best for
University researchers
The Individual plan at €360 a year and the training mode in the trial let a single investigator learn the tool before paying for a live study.
Hospital registry teams
Ledidi Core covers data capture forms and statistical analysis for registries and audits, and Ledidi Admin adds user activity logs and project governance across departments.
Small sponsors running a first trial
The Basic Trial price covers a defined participant and site band, so the budget for an early phase study can be fixed before activation.
Ledidi plans and pricing
| Plan | Price | What it includes |
|---|---|---|
| Individual | €360 per year | One user and up to 1,000 entries per project, aimed at solo researchers. Suited to small audits, pilot registries or a thesis project. |
| Team | €1,500 per year | Five users, external collaborators and role-based access control. Clinical trials are priced per study on this plan. |
| Organisation | €6,000 per year | Twenty users, organization-wide user and project management and portfolio oversight. Adds portfolio oversight, so a department head can see every project in one place, and it suits organizations running several registries. |
| Basic Trial | €9,500 for 12 live months | Up to 50 participants and 3 sites, then €417 per month after year one. Extra participant and site bands cost more. |
Checked November 2026.
What Ledidi does
- AI Study Builder
- After a protocol is uploaded, the tool drafts visits, visit windows, unplanned events, attached forms and participant-reported surveys. Staff review and edit all of it before the study goes live.
- Training mode
- During the trial, teams can build and practice a study in training mode at no cost as long as the project is not taken live, which lowers the risk of a first build.
- Built-in statistics
- Ledidi Core generates Kaplan-Meier curves, scatter plots and other analyses inside the platform, so researchers can look at interim results without exporting to another package.
- Admin governance
- Ledidi Admin provides user activity logs and secure project access for organizations that need oversight across several registries or studies. This helps hospitals and universities answer who changed which record.
- Trials audit documentation
- The trust centre says a Trials Audit Report covering GxP, 21 CFR Part 11 and ICH GCP is available on request. Request it early, because quality teams usually ask for it before a first live study.
How Ledidi handles your data
Ledidi's trust centre says the platform runs with Amazon Web Services and lists independently audited ISO/IEC 27001, third-party verified HIPAA rules, a SOC 2 Type II report covering May 2025 to April 2026, the NHS Data Security and Protection Toolkit and UK Cyber Essentials. The home page describes confidential computing and end-to-end encryption. No hosting region, retention period or subprocessor list was stated, and the page does not say how the AI Study Builder uses customer data. A Data Processing Addendum and Data Flow Diagram are available on request.
Where Ledidi falls short in practice
- Region not named. The trust centre mentions AWS but not a region. European sponsors with residency rules must ask for the AWS documentation and the data flow diagram before signing.
- AI availability unclear. The pricing page lists the AI study builder among the Trials features but does not say which plans include it, so confirm scope in the quote.
- Trial pricing grows with size. Participant and site bands beyond the Basic Trial add cost. A multi-country study with many sites should ask for a full quote, not the headline €9,500.
Works with
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Ledidi: common questions
How much does a Ledidi clinical trial cost?
The pricing page gives a Basic Trial example at €9,500 for twelve live months, covering up to 50 participants and 3 sites. Adding a Team subscription brings the example total to €11,000. After the first year the Basic Trial costs €417 a month, and more participants or sites cost extra.
Can I try Ledidi before paying?
Yes. The pricing page offers a free 30-day trial, which the FAQ says is a Team plan trial with standard features. Teams can build and practice studies in training mode at no cost as long as the project is not taken live.
What does Ledidi's AI Study Builder produce?
It takes an uploaded protocol and drafts the study structure, including visits and visit windows, unplanned events, attached forms and participant-reported surveys. The product page says your team reviews and edits everything before it goes live. Because the output is a draft, check visit windows against the protocol line by line.
Which certifications does Ledidi list?
The trust centre lists ISO/IEC 27001, HIPAA verification as of April 30, 2026, a SOC 2 Type II report, the NHS Data Security and Protection Toolkit self-assessment and UK Cyber Essentials. A Trials Audit Report on GxP, 21 CFR Part 11 and ICH GCP is available on request.
Is Ledidi suitable for registries as well as trials?
Yes. Ledidi Core is built for registries, clinical audits and research projects, with data capture forms, collaboration and statistics, while the Trials module adds clinical trial setup and management. The subscription tiers apply to both uses. The pricing page prices registries and trials separately, so confirm which route applies to your project.