Croatia is an EU member state, so medicine trials run under the Clinical Trials Regulation with HALMED and a Central Ethics Committee. Capture is a self-serve cloud EDC, hosted in Frankfurt, that needs no local IT or CRO to start.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Croatia
Key points for studies in Croatia
Regulation
For a medicine trial, the sponsor files in CTIS. HALMED, the Agency for Medicinal Products and Medical Devices, handles the medicines side and the Central Ethics Committee handles ethics. How the two split Part I and Part II work in practice is not set out in the sources we found, so confirm it with them. For the EU procedure itself read our EU CTIS submission guide and EU CTR clinical trial software.
The data system supports the dossier by showing what is collected. Capture exports a blank eCRF PDF with cover page, form index, visit-by-form matrix and every approved form empty. Later, inspectors look at traceability, and every field change in Capture carries timestamp, user, old and new value and reason, in a trail that cannot be edited through the interface. See audit trail software for clinical trials.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
Small-market realities
| Need | Why in a smaller market | How Capture helps |
|---|---|---|
| No local IT or validation staff | Hospital research units are small. | Cloud EDC; build and test in the sandbox, no installation. |
| Join a multinational study | Croatian sites often join studies led abroad. | Site-level participant numbering and by-site exports. |
| Investigator-led studies | Funding for a CRO is limited. | Self-serve setup; no enterprise sales call required. |
| Inspector-ready records | Few staff to prepare for inspection. | Field-level audit trail, e-signatures and queries by default. |
| Translations | Local-language consent is normal. | Wording is yours; language screens are not claimed. |
Capture is the data system, not a CRO. Confirm regulatory detail with HALMED and the committee.
Build the forms free, check the edit checks with your site team and share the blank eCRF PDF. Pay only when participants enrol.
Data protection
Croatian trial data is personal data under the GDPR, and health data is a special category. The national supervisory authority is AZOP (the Personal Data Protection Agency). Sources we searched did not describe its trial guidance, so confirm with your data protection officer. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia), so a Croatian study can keep storage in the EU.
Site coordinators see participant names while researchers see coded IDs, enforced by row-level security. Data is encrypted with AES-256 at rest and TLS in transit. Read GDPR compliant clinical trial software and GDPR DPIA template for clinical trials.
Site coordinator
Jane Peterson
DOB: 04-Mar-1978
Subject 01-004
Sees direct identifiersResearcher
Subject 01-004
DOB: withheld
Coded ID only
Sees coded ID onlySame record, two roles. Row-level security enforces the split.
Enrolment
Participants can enrol by scanning a site-specific or study-specific QR code, with no app to install. Each site gets its own participant numbering (for example 001-0042) and its own coordinator portal, and exports can be filtered by site. Croatian-language screens are not claimed on this page.
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Print it on posters and clinic flyers
Typical start-up
A sketch, not a regulatory timeline.
Confirm CTIS status and who files: sponsor or legal representative.
Get HALMED and committee expectations directly.
Build in the sandbox with site staff.
Include it as supporting detail.
Create accounts as each site is ready.
Research landscape
Croatian university hospitals in Zagreb, Split, Rijeka and Osijek take part in multinational studies and academic projects. Neighbouring pages cover Slovenia, Hungary, Bulgaria, Italy and the Central and Eastern Europe overview.
For funded academic work read EDC for academic clinical trials.
Medicinal product trials run under EU Regulation 536/2014, with HALMED and the Central Ethics Committee named by consultancies as the national bodies. Confirm current procedure with them.
We did not find reliable official figures. Ask HALMED and the committee, and plan from the regulation's timelines for multinational dossiers.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Frankfurt keeps Croatian study data in the EU. There is no Croatian data centre or office.
No regulator approves EDC software in that way. Capture provides an audit trail, e-signatures and role-based access, and your validated use is what is reviewed.
Capture is self-serve and runs in the cloud. Whether your sponsor or regulation requires a CRO or local representative is a separate question to ask HALMED.
This page does not claim multilingual participant screens. Ask us about current language support before designing a Croatian ePRO or consent flow.
Yes. The free sandbox has every feature with no credit card and no time limit. You pay only when you go live with real participants.
Keep exploring
Clinical trial software in Slovenia
Neighbouring EU market.
Clinical trial software in Hungary
Central European sites.
Central and Eastern Europe
Regional view.
EU CTIS submission guide
How the EU portal works.
GDPR compliant clinical trial software
Processor and hosting questions.
Pricing
Free sandbox, pay at go-live.
Build, test and share the blank eCRF PDF before any fee. You pay only when real participants enrol.