Run your trials inside your German hospital.
How ZINOS fits the Medical Research Act, BfArM and PEI review, and German rules on health data in the cloud.
Trial approval in Germany.
National trials are assessed within 26 days of validation, by BfArM or PEI and a registered ethics committee.Sourcepei.dePaul-Ehrlich-Institut, procedures and deadlines, 6 June 2025
- Protocol and dossier
- Submission through CTISSourceema.europa.eu
- BfArM or PEISourcePaul-Ehrlich-Institut, procedures and deadlines, 6 June 2025
- Registered ethics committeeSourceBfArM, press release 8/25, 30 June 2025; AMG s. 41a and 41c
- 26-day national assessmentSourcepei.de
- Trial conduct
German rules, and how ZINOS fits.
- Medical Research Act, since October 2024: approvals tracked per studySourcePaul-Ehrlich-Institut, Medizinforschungsgesetz
- Health data clouds only in the EU, EEA, or Switzerland: hosted in-houseSourceSection 393 SGB V; Rödl & Partner, 30 October 2025
- Electronic consent under eIDAS: signed eICF with audit trailSourceAMG s. 40b; BIOPRO Baden-Württemberg, January 2026
- Health Data Use Act: hospitals may research their own dataSourceFederal Ministry of Health, Daten für die Forschung und Versorgung
Where the record sits in Germany.
With on-premise deployment, BfArM, PEI, and the ethics committee receive what the rules require, and the trial record stays inside your hospital.Sourcepei.dePaul-Ehrlich-Institut, procedures and deadlines, 6 June 2025
- Hospital information system
- Laboratory system
- Imaging and pathology
- Identity and access
- Site operating system
- Data hub
- Local AI node
- Audit trail
Scoped access
- Ethics committee
- BfArM or PEI
- Sponsor
- Monitor
German requirements, mapped to ZINOS.
| Requirement | Rule | ZINOS capability |
|---|---|---|
| Health data processed in the cloud | Section 393 SGB VSourceSection 393 SGB V; Rödl & Partner, 30 October 2025 | On-premise deployment in your hospital |
| Ethics review before start | Registered committees; specialised committee at BfArMSourceBfArM, press release 8/25, 30 June 2025; AMG s. 41a and 41c | Approval tracking in the site file |
| Electronic consent | Section 40b AMG, eIDASSourceAMG s. 40b; BIOPRO Baden-Württemberg, January 2026 | Tablet eICF with audit trail |
| 25-year trial file retention | Clinical Trials Regulation, Art. 58SourceRegulation (EU) No 536/2014, Art. 58, eur-lex.europa.eu | Configurable retention and archival |
| Each row states a design fact about ZINOS, not a compliance claim. | ||
See ZINOS against German rules.
Book a call on running trials in Germany, and bring your DPO.