Run your trials inside your Swedish hospital.
How ZINOS fits Swedish Medical Products Agency and ethics review, and Swedish rules on patient data.
Trial approval in Sweden.
The Medical Products Agency decides, with the Swedish Ethical Review Authority's opinion on both parts.SourceEtikprövningsmyndigheten, 15 April 2026
- Protocol and dossier
- Submission through CTISSourceema.europa.eu
- Ethical Review Authority opinionSourceEtikprövningsmyndigheten, 15 April 2026
- Medical Products Agency decisionSourceEtikprövningsmyndigheten, 15 April 2026
- Trial conduct
Swedish rules, and how ZINOS fits.
- Patient Data Act allows feasibility counts; access is loggedSourceRiksdagen, Prop. 2022/23:31
- Public hospitals: data shared only for technical storage; on-premise deploymentSourceRiksdagen, Prop. 2022/23:97 (Secrecy Act ch. 10 s. 2a)
- Electronic consent accepted: identity verified, consent documentedSourceEtikprövningsmyndigheten FAQ, 25 April 2023
Where the record sits in Sweden.
With on-premise deployment, the agency and the Ethical Review Authority receive what the rules require, and the trial record stays inside your hospital.SourceEtikprövningsmyndigheten, 15 April 2026
- Hospital information system
- Laboratory system
- Imaging and pathology
- Identity and access
- Site operating system
- Data hub
- Local AI node
- Audit trail
Scoped access
- Ethical Review Authority
- Medical Products Agency
- Sponsor
- Monitor
Swedish requirements, mapped to ZINOS.
| Requirement | Rule | ZINOS capability |
|---|---|---|
| Ethics opinion before start | Swedish Ethical Review AuthoritySourceEtikprövningsmyndigheten, 15 April 2026 | Approval tracking in the site file |
| Feasibility counts on patient data | Patient Data Act, since May 2023SourceRiksdagen, Prop. 2022/23:31 | Counts on your own records, logged |
| Disclosure to technical providers | Secrecy Act, ch. 10, s. 2aSourceRiksdagen, Prop. 2022/23:97 (Secrecy Act ch. 10 s. 2a) | On-premise deployment in your hospital |
| 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 Swedish rules.
Book a call on running trials in Sweden, and bring your DPO.