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ZINOS
A Danish hospital of pale brick and timber at first light, low winter sun over grass; no people.

Run your trials inside your Danish hospital.

How ZINOS fits Danish Medicines Agency and ethics review, and Danish rules on research data leaving the EU.

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Trial approval in Denmark.

The Danish Medicines Agency and a Medical Research Ethics Committee assess each application together.

  1. Protocol and dossier
  2. Submission through CTIS
  3. Joint agency-ethics review
  4. Expedited phase I
  5. Trial conduct

Danish rules, and how ZINOS fits.

  • Research data processed outside the EU needs permission; records stay inside
  • Device investigations: agency and ethics committee in parallel
  • Trial Nation, since 2018: one system across studies

Where the record sits in Denmark.

With on-premise deployment, the agency and the ethics committee receive what the rules require, and the trial record stays inside your hospital.

  • 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
  • Danish Medicines Agency
  • Sponsor
  • Monitor

Danish requirements, mapped to ZINOS.

RequirementRuleZINOS capability
Joint review before startDanish Medicines Agency and ethics committeesApproval tracking in the site file
Research data leaving the EUData Protection Act, s. 10(3)On-premise deployment in your hospital
Device investigationsAgency and ethics authorisationVersioned, signed submission documents
25-year trial file retentionClinical Trials Regulation, Art. 58Configurable retention and archival
Each row states a design fact about ZINOS, not a compliance claim.
A Danish hospital of pale brick and timber at first light, low winter sun over grass; no people.

See ZINOS against Danish rules.

Book a call on running trials in Denmark, and bring your DPO.

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