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ZINOS
A Portuguese hospital of white render and pale stone at first light, above the sea; no people.

Run your trials inside your Portuguese hospital.

How ZINOS fits INFARMED and CEIC review under the 2026 clinical trials law, and Portuguese data rules.

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Trial approval in Portugal.

Under Law 9/2026, INFARMED decides, and the CEIC's ethics opinion binds the decision.

  1. Protocol and dossier
  2. Submission through CTIS
  3. INFARMED assessment
  4. CEIC opinion, binding
  5. Trial conduct

Portuguese rules, and how ZINOS fits.

  • Need-to-know access to health data: role-based, every view logged
  • Device investigations under Law 71/2025: documents tracked
  • Research data minimised and pseudonymised: configured folder by folder

Where the record sits in Portugal.

With on-premise deployment, INFARMED and the CEIC 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
  • CEIC
  • INFARMED
  • Sponsor
  • Monitor

Portuguese requirements, mapped to ZINOS.

RequirementRuleZINOS capability
Ethics opinion before startLaw 9/2026Approval tracking in the site file
Access to health dataLaw 58/2019, Art. 29Role-based access, every access logged
Device investigationsLaw 71/2025Versioned, 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 Portuguese hospital of white render and pale stone at first light, above the sea; no people.

See ZINOS against Portuguese rules.

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