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ZINOS
A Belgian hospital of brick and stone at first light, a quiet square with lime trees; no people.

Run your trials inside your Belgian hospital.

How ZINOS fits FAMHP review, the College's ethics allocation, and Belgium's Health Data Agency.

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Trial approval in Belgium.

The FAMHP assesses the trial, and the College designates an ethics committee other than the site's own.

  1. Protocol and dossier
  2. Submission through CTIS
  3. FAMHP assessment
  4. College-designated ethics committee
  5. Trial conduct

Belgian rules, and how ZINOS fits.

  • Faster FAMHP timelines since January 2026: approvals tracked per study
  • Health Data Agency: datasets described from one governed record
  • Ethics committee assigned independently: submission documents versioned

Where the record sits in Belgium.

With on-premise deployment, the FAMHP 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
  • FAMHP
  • Sponsor
  • Monitor

Belgian requirements, mapped to ZINOS.

RequirementRuleZINOS capability
Ethics opinion before startLaw of 7 May 2017Approval tracking in the site file
Secondary use of health dataHealth Data Agency, Law of 14 March 2023Governed data hub
Accelerated national assessmentFAMHP timelines from 2026Versioned, 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 Belgian hospital of brick and stone at first light, a quiet square with lime trees; no people.

See ZINOS against Belgian rules.

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