Ledidi Trials: Self-Serve EDC for Clinical Trials

Get started in minutes.

Upload your protocol and the AI Study Builder drafts your eCRFs, or build them yourself in the form builder. EDC and clinical data management in one place, audit-ready for 21 CFR Part 11.

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Built and verified for regulated clinical research

How it works

Build the study yourself

No setup project and no waiting on a vendor. Design the study, train your team and go live on your own, and we’re here if you want help.

  1. 1

    Upload your protocol.

    Vic reads it and proposes the visit schedule and the forms each visit needs.

    • Visits with ± day windows, and unplanned events
    • Forms, participant surveys and randomisation
    • PDF, Word, Excel, CSV or text protocols
    The Build with AI page. The study is described as a 12-month cohort after total knee replacement, the protocol KNEE-OUTCOMES_protocol_v2.1.pdf is attached, and Ask first is selected so Vic asks before each change.
  2. 2

    Review and refine.

    Edit your eCRFs in the visual form builder, or tell Vic what to change in plain language.

    • Range and date checks, and conditional questions
    • Calculated fields, file uploads and medical coding
    • Vic sees your study design, never the data you collect
    The form builder with Physiotherapist notes selected and marked required in the rehabilitation session form. Beside it, Vic confirms it renamed the field and made it required, saved to a draft of the form.
  3. 3

    Practise in training mode.

    Your team enters training participants in their real study roles, kept apart from live data.

    • Same forms, visits and roles as the live study
    • Training data never mixes with live data
    • Find gaps in the design before go-live
    Participants list in training mode: training participants at Oslo Orthopaedic Centre with their status and progress through screening, baseline, 6-week and 6-month follow-up visits.
  4. 4

    Go live when you’re ready.

    Invite your sites and team and assign roles. Then take the study live from its settings.

    • Custom study and site roles, scoped to each site
    • A fixed price from your participant and site counts
    • Help from Ledidi’s data managers if you want it
    The Go live dialog: settings that will be locked, such as randomisation, participant identifier and electronic signature verification, then the visit schedule with the forms in each visit, and a checkbox to confirm that going live is irreversible.
Run the study

Built specifically for every role in a clinical trial.

Site overview for Bergen Orthopaedic Centre: enrolment counts, five visits in progress, planned 6-week and 6-month follow-ups, adverse and serious adverse events, and open queries.
Participant BER-00011 at the 6-week follow-up: the visit timeline, the completed knee function and imaging forms, and a rehabilitation session form being filled in with activities, session length and therapist notes.
  • Visit timelineSee what is done, what is due and when.
  • Informed consentRecord the consent version and date for each participant.
  • Adverse eventsReport an AE or SAE from the participant page at any time, even while the database is frozen.
Monitor overview for Bergen Orthopaedic Centre: unplanned events with SDV status, open queries on height, implant lot number and knee flexion, and SDV status per participant and visit.
A query on the height answer for participant BER-00008: the monitor asks to verify the value against the screening record and the site replies that it was measured on the day of surgery.
  • QueriesRaise a query on any answer, discuss it with the site and resolve it.
  • Source data verificationVerify single answers or whole forms. SDV status is included in exports.
  • Monitor overviewOpen queries, flagged items and safety events, site by site.
Study overview across all three sites: 38 participants included or completed, 6 safety-related events and 9 open queries, with participants and queries per site and adverse and serious adverse events by site.
The form builder: variable types on the left, the imaging and wound review form used at both follow-ups in the middle, and settings for the wound description on the right, shown only when a wound concern is reported.
Vic, the AI study builder, beside the visit list: asked to add a 12-month follow-up with a ±30 day window and the same forms as the 6-month visit, it adds the visit with the three existing follow-up forms.
  • Study overviewParticipants, queries and safety events per site, across the whole study.
  • Form versionsPublish changes mid-study without losing history.
  • Rich field typesNumbers, categories, dates, scales, files and calculations. Medical coding with ICD-10, ICD-11, IMDRF and MedDRA (licence required).
  • Logic and checksShow questions conditionally. Range and date checks warn at entry and can require an explanation.
  • AI Study BuilderDescribe a change in plain language. Vic suggests it for you to review and accept.

Visits and windows

Visits with ± day windows, out-of-window warnings and missing visits recorded with a reason.

Participant surveys

Sent by email or SMS. Participants answer with a code, no account needed.

Randomisation

Stratified block randomisation with weighted arms and stratification by site.

Electronic signatures

Sign off each participant record to lock it. Optionally require a PIN code to sign.

Queries and SDV

Query any answer. Verify single answers or whole forms.

Training mode

Practice data kept apart from real study data.

Study documents

Versioned documents shared by study or site role, with every download logged.

Exports

CSV, Excel, JSON or SPSS, plus change and access logs.

Transparent pricing

Build and test free. Pay when you go live.

Running an academic study? Contact us.

Calculate your study cost

Set your participant and site counts, then choose how long your study will run.

Included in the Basic Trial

Included in the Basic Trial

Minimum 12 months

See bands and prices

The Basic Trial covers up to 50 participants and 3 sites. Above that, each band adds one fixed monthly price, and every count within the same band costs the same.

For example, 51 to 100 participants add €55/month. Entering 101 moves you to the 101–150 band at €90/month, which replaces the previous band price. Add your site band to get the monthly total.

Participant bands
BandAdded per month
Up to 50Included
51–100€55
101–150€90
151–250€125
251–500€175
501–1,000€245
1,001–2,500€350
2,501–5,000€440
5,001–10,000€510
10,001–20,000€580
Site bands
BandAdded per month
Up to 3Included
4–5€80
6–10€260
11–15€410
16–20€545
21–25€665
26–30€770
31–40€950
41–50€1,100
51–100€1,700
101–200€2,900

After the first 12 months, the Basic Trial costs €417 per month.

File storage limitations

If you expect your study’s files to total more than 50 GB, contact us before going live to discuss your storage needs.

Professional services

Ledidi’s data managers can help with study setup and role management on a consultancy basis. Contact us to discuss your study’s needs.

Your study · 12 live months

€11,000total for 12 live months
Basic Trial, first 12 months
€9,500
Team subscription, €1,500 × 1 year
€1,500
When you pay for the study

Invoiced at go-live€9,500

The Basic Trial covers up to 3 sites and 50 participants, with every feature included. Prices exclude VAT.

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Frequently asked questions

Can't find what you're looking for? Contact us.

Ledidi Trials was independently audited in January 2026 and confirmed audit-ready for GxP-regulated clinical trials, covering FDA 21 CFR Part 11, ICH GCP E6(R3) and ISPE GAMP 5. The audit confirmed that it meets the supplier-side expectations for electronic records, audit trails, role-based access control and electronic signatures. As with any system, validation for your intended use remains with your organisation. You can request the audit report to support your vendor qualification.

We know how much work software validation is for a sponsor, so we do most of the groundwork for you. Every change to Ledidi Trials goes through a verification process that follows GAMP 5. With each release you get a summary of everything that can affect a running study, along with documentation you can use in your own validation and risk assessment. Contact us to find out more.

Both. Site staff enter data in eCRFs, as in an EDC, and the same system handles the data management: queries, source data verification, medical coding with ICD-10, ICD-11, IMDRF and MedDRA (licence required), electronic signatures, and exports with change and access logs. You don't need a separate EDC and CDMS. Read more about the difference between EDC and CDMS.

Upload your protocol as a PDF, Word, Excel, CSV or text file, and Vic, the AI Study Builder, proposes the visit schedule and the eCRFs each visit needs. You review and accept every change, and you can ask Vic for edits in plain language or work directly in the form builder. Vic sees your study design, never the data you collect.

Yes. Building and testing your study is free. In training mode, your team enters training participants in their real study roles, kept apart from live data, so you can find gaps in the design before go-live. You pay when you take the study live, and Ledidi's data managers can help with setup on a consultancy basis if you want.