Run your trials inside your Swiss hospital.
How ZINOS fits the Human Research Act, the Clinical Trials Ordinance, and Swiss data protection law.
Trial approval in Switzerland.
Medicinal-product trials in categories B and C, and device trials in category C, also need Swissmedic authorisation.Sourceeasy-gcs.ch
- Protocol and dossier
- Ethics review via BASECSourcebag.admin.ch
- Swissmedic, where requiredSourceeasy-gcs.ch
- Approvals received before startSourceswissmedic.ch
- Trial conduct
- Results summary publishedSourceswissmedic.ch
- ClinO: 20-year retentionSourceeasy-gcs.ch
Swiss rules, and how ZINOS fits.
- 20-year ClinO retention: configurable retention and archival policySourceeasy-gcs.ch
- Electronic consent, permitted since November 2024: eICF with signaturesSourceswissethics.ch
- Cantonal or federal data law: records stay under your controlsSourcesctoplatforms.ch
Where the record sits in Switzerland.
Under on-premise deployment, ethics committees and Swissmedic receive what the law requires, and the trial record stays on your servers.Sourcebag.admin.cheasy-gcs.ch
- Hospital information system
- Laboratory system
- Imaging and pathology
- Identity and access
- Site operating system
- Data hub
- Local AI node
- Audit trail
Scoped access
- Cantonal ethics committee
- Swissmedic
- Sponsor
- Monitor
Swiss requirements, mapped to ZINOS.
| Requirement | Rule | ZINOS capability |
|---|---|---|
| Ethics approval before start | HRA, ClinOSourcebag.admin.chswissmedic.ch | Approval tracking in the site file |
| Swissmedic authorisation | ClinO B and C; ClinO-MD CSourceeasy-gcs.ch | Versioned, signed submission documents |
| Electronic consent | ClinO Art. 7cSourceswissethics.ch | Tablet eICF with audit trail |
| Retention of at least 20 years | ClinO Art. 45Sourceeasy-gcs.ch | Configurable retention and archival |
| Data protection | Revised FADP or cantonal lawSourcesctoplatforms.ch | On-premise deployment, configurable pseudonymisation |
| Each row states a design fact about ZINOS, not a compliance claim. | ||
See ZINOS against Swiss rules.
Book a call on running trials in Switzerland, and bring your DPO.