Tool profile
Climedo: cost, fit and limits
Climedo is a clinical data capture platform made by Climedo Health GmbH of Munich that combines EDC, eCOA and ePRO, eConsent and televisits with AI tools for study setup and data entry. Sponsors, device makers and investigators use it for trials, decentralized and hybrid studies, and real-world evidence.
What to know first
Climedo markets three AI tools next to its EDC: an AI Study Configurator that turns a protocol into forms and edit checks, Autonomous Data Capture that moves source data into the record, and AI Medical Coding. Imported values wait for human approval before they reach the form. Pricing is a monthly software fee per active study plus a one-time set-up fee, billed annually in advance, and no figures are printed. All servers are in Frankfurt according to the home page.
Climedo at a glance
| Maker | Climedo Health GmbH, Germany |
|---|---|
| Free plan | Free trial only |
| Entry price | Quote only |
| API access | Yes |
| Category | Best AI Clinical Trial Software in 2026, rank 2 of 11 |
| Website | climedo.de |
Who Climedo is best for
German and EU device makers
Frankfurt hosting, a Munich legal entity and a described GAMP 5 validation approach fit teams that must explain their supplier to a notified body or ethics committee.
Sponsors with many sites
Every package includes unlimited users and unlimited sites, so adding a clinic or investigator does not change the monthly fee.
Teams digitizing source capture
Voice entry, PDF upload, phone photos and EHR connections feed one review queue where data managers approve values before they reach the case report form.
Climedo plans and pricing
| Plan | Price | What it includes |
|---|---|---|
| Core package | Monthly fee per active study plus set-up fee | Unlimited users and sites, data collection by SMS, email link or QR code, edit checks, queries, dashboards, serious adverse event reporting and exports. |
| Support levels | Bronze, silver or gold | Support comes in three packages, but the pricing page does not say what separates them. Onboarding, set-up and maintenance are part of the fee. |
| Contract terms | Annual, paid in advance | The minimum contract is normally one year, cancellation is possible three months before it ends, and a short pilot can come first. |
| AI and automation tools | Not itemized | ADC, AI Study Configurator and AI Medical Coding are listed in navigation, and the pricing page does not say which package includes them. |
Checked November 2026.
What Climedo does
- AI Study Configurator
- The tool builds eCRFs, ePRO forms, serious adverse event forms and edit checks from a protocol, with team approval at each step. The page claims a launch in 3 to 5 days, a vendor figure.
- Autonomous Data Capture
- Source values arrive by voice, PDF scan, phone photo or EHR link. The AI maps them to fields, shows confidence scores, converts units and accepts input in any language.
- Four-eye principle
- Imported data requires human sign-off before it reaches the eCRF, and a full audit trail records who approved what, which keeps the regulated record intact.
- Hybrid study tools
- eCOA, ePRO, eConsent and televisits are in the same system, so a decentralized study does not need a second vendor for patient-facing steps. Participants can respond from a phone link without installing anything.
- Dashboards and visualization
- Dashboards and smart views show data status for study staff, and exports are available in CSV, XLSX or PDF. The pricing page also lists edit checks, queries and serious adverse event reporting.
How Climedo handles your data
Climedo's home page says all servers sit in Frankfurt on AWS, with US hosting available on request, and that its hosting partner holds ISO 27001. The compliance page describes ISO 9001:2015, GAMP 5 (2022) validation, Annex 11, 21 CFR Part 11, GDPR and HIPAA alignment, a data processing agreement, penetration tests and data protection audits. The pages did not say how the AI tools use customer data or whether data trains any model. Imported values need human approval, and an audit trail is kept.
Where Climedo falls short in practice
- No printed price. The FAQ describes the fee structure, but no figure appears. A budget needs a proposal, and the minimum term is one year. Plan for a proposal cycle before comparing it with printed rivals.
- AI inclusion unclear. Navigation lists three AI solutions, and the pricing page does not say whether they sit in the base fee. Ask for each module to be itemized.
- AI data use not addressed. The compliance page covers validation and data protection but not whether AI processing happens in Frankfurt or whether customer data trains models. Ask for this in the data processing agreement.
Works with
Alternatives to Climedo
Climedo: common questions
How does Climedo charge for a study?
The pricing FAQ describes a monthly software fee per active study or survey and a one-time set-up fee based on service scope. Billing is annual and paid in advance, and the page prints no amounts. A short pilot can come before the annual contract.
Where are Climedo servers located?
The home page says all servers are in Frankfurt on AWS, with US hosting available on request, and that the data sits with an ISO 27001-certified hosting partner. It also says the set-up was reviewed at federal level by the BSI and BfDI.
Can Climedo's AI write directly into the case report form?
No. The home page says imported data requires human sign-off before it reaches the eCRF, with confidence scores, a four-eye principle and a full audit trail. The AI Study Configurator also waits for team approval at each build step. Teams should still sample the approved values against source documents.
Does Climedo support decentralized trials?
Yes. The product list includes eCOA and ePRO, eConsent and televisits, and the home page names hybrid and decentralized study types and real-world evidence. Data collection can start from an SMS or email link or a QR code. The pricing page also lists unlimited users and sites in every package.
What validation approach does Climedo describe?
The compliance page describes a risk-based approach with an agile V-model under GAMP 5 (2022), regularly audited by pharma customers and external reviewers. It lists ISO 9001:2015, ICH GCP, Annex 11, 21 CFR Part 11, HIPAA and GDPR alignment. Customers and external reviewers audit the validation regularly, according to the page.