Ledidi, an Oslo company, describes Ledidi Core as a cloud platform for research projects and clinical registries with built-in statistics. Whether you need an alternative depends on whether your project is a registry or audit, or a regulated trial that must meet GCP and Part 11 expectations.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Registry or audit project | Regulated clinical trial | |
|---|---|---|
| Flexible forms, quick start | Core need | Needed |
| Analysis inside the platform | Often valued | Usually done in statistical software |
| Field-level audit trail with reasons | Useful | Required in practice |
| Query workflow and SDV | Optional | Core need |
| Randomisation and blinding | Rare | Common |
| Electronic consent and signatures | Sometimes | Common |
What to know first
The vendor
Library and procurement listings describe Ledidi Core as an end-to-end software-as-a-service tool for research and registries, optimised for multi-centre work, with granular access rights so collaborators can share a database without seeing each other's records, while analyses can run across the full dataset. The same listings describe form building, data visualisation and a statistics module. News coverage reports an NHS trust pilot and a clinical audit in the UK, and a regional health authority agreement in Norway.
Ledidi Trials is described separately, as an extension for regulated clinical trials, and the vendor makes its own claims about GCP and Part 11 functionality. Those claims are the vendor's to prove: ask for the documentation, a sample audit trail, and a walkthrough of query and signature workflows. The checks in the 21 CFR Part 11 compliance checklist and the EDC vendor audit checklist apply to this vendor as to any other.
Data protection is its own subject. Norwegian and UK health data sit under GDPR-family rules plus national health law, and the rules differ between a clinical audit and a trial. Check with your data protection officer or local counsel before choosing a platform for either.
Decision matrix
The middle column is a question, not an answer.
| Question | Ask Ledidi | Capture's answer |
|---|---|---|
| Which edition covers my project? | Core, Trials or both, and what each includes. | One platform; Core and Full Platform differ by modules, not by a registry/trial split. |
| In-platform statistics | Which tests, and can I export the code or results? | None built in. Exports: CSV/Excel with data dictionary, SDTM as SAS XPT with Define-XML. |
| Audit trail | Sample export with reasons for change. | Field-level: user, time, old value, new value, reason; exportable. |
| Queries and monitoring | Show edit checks, auto-queries and SDV. | Range high/low and custom checks raise auto-queries; SDV can be set per field. |
| Patient-reported data | Is ePRO included? | ePRO in Core, with diaries and questionnaires. |
| Consent | Is electronic consent included? | eConsent in Core with email-OTP verified e-signatures and countersignature. |
| Randomisation | Simple, stratified, blinded? | Simple in Core; stratified and blinded in Full Platform. |
| Access control | Roles and cross-site visibility. | Researcher, site coordinator and admin roles; site coordinators see participant names, researchers see coded IDs. |
| Price | Written quote. | Core $1,000/month incl. one live study + $50 per participant per month. Full $5,000 + $30. Enterprise custom. |
Build both in the free sandbox: one participant-reported registry form and one site-completed eCRF with edit checks. No credit card, no time limit.
Choosing
First, who will inspect the data? If an ethics board, funder or regulator will ask how a value changed and who approved it, you need the trial controls, whatever the project is called. A routine clinical audit run by a hospital team, which is a different category, may not. See clinical audit and quality improvement data collection.
Second, is there an intervention you assign? Assigned treatments mean randomisation, blinding, safety follow-up and consent. Observational registries rarely do. For the observational side, read EDC for registry studies and EDC for real-world evidence studies.
Third, where will analysis happen? If your analysts already work in R, SAS or Stata, an in-platform statistics module saves little and a clean export saves a lot. If your clinicians run their own analysis without a statistician, built-in tools may be exactly what you want, and no EDC with only exports will replace them.
Will a regulator, ethics board or sponsor audit it?
Yes: trial controls needed
Do you assign an intervention?
Yes: randomisation, safety, consent
Where does analysis happen?
Export to R/SAS, or in-platform
Test the shortlist on one form set
Same forms in each tool
Fair view
Stay if your project is a multi-centre registry or audit, your clinicians value analysis in the same tool, and the existing deployment is agreed with your hospital or health authority. Replacing a registry mid-life loses continuity of data definitions. If you must move, how to switch EDC vendors mid-study covers the principles.
Look elsewhere if the project has become, or is about to become, a regulated trial and your sponsor wants the evidence a trial EDC gives. Academic teams moving from a research-project tool into an investigator-initiated trial often face this step; see EDC for investigator-initiated trials and EDC for academic clinical trials. European university teams may also want clinical trial software for European universities for regional context.
Related comparisons
The common research database for academic teams.
Read more CompareFull head-to-head.
Read more AlternativesA cloud EDC used in research and trials.
Read more RegionRegional notes for UK studies.
Read moreA Norwegian company. Ledidi Core is described in library and procurement listings as a cloud platform for research projects and clinical registries with form building and built-in statistics. Confirm scope with the vendor.
Public sources describe Core as the research and registry platform and Trials as an extension for regulated clinical trials. Ask the vendor exactly what each includes and which your project needs.
No. Capture exports CSV or Excel with a data dictionary, and SDTM datasets as SAS XPT with Define-XML, for analysis in your statistical software.
Yes, including participant-reported data. See the page on EDC for registry studies. If in-platform analysis is essential, compare that need directly.
No. Capture is hosted in the EU (Frankfurt) and USA (N. Virginia). Check with your data protection officer what your project requires.
Yes. The free sandbox has every feature, with no credit card and no time limit.
Yes. Capture is suitable for Phase 1 to 3.
Keep exploring
EDC for registry studies
Observational data collection.
REDCap alternatives
The common academic option.
Compare with REDCap
Full head-to-head.
EDC for investigator-initiated trials
Moving from project to trial.
Clinical audit data collection
Audit versus trial controls.
Pricing
Core, Full Platform and Enterprise.
Free sandbox with every feature. No credit card, no sales call, and you pay only once you go live.