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ZINOS
A French teaching hospital of pale stone at first light, a courtyard and tall windows; no people.

Run your trials inside your French hospital.

How ZINOS fits ANSM and CPP review, health data hosting rules, and the CNIL's research methodologies.

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Trial approval in France.

Applications go through CTIS; ANSM assesses, and a CPP drawn at random gives the ethics opinion.

  1. Protocol and dossier
  2. Submission through CTIS
  3. ANSM assessment
  4. CPP, allocated by draw
  5. Fast track, where eligible
  6. Trial conduct

French rules, and how ZINOS fits.

  • Hosting care data needs HDS certification; ZINOS runs on hospital servers
  • CNIL research methodologies: pseudonymisation configurable, access logged
  • Fast track since March 2026: approvals tracked study by study

Where the record sits in France.

With on-premise deployment, ANSM and the CPP 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
  • CPP
  • ANSM
  • Sponsor
  • Monitor

French requirements, mapped to ZINOS.

RequirementRuleZINOS capability
Hosting of health data from careHDS certification, version 2On-premise deployment in your hospital
Ethics opinion before startCPP, allocated by the CNRIPHApproval tracking in the site file
Research on health dataCNIL MR-001 and MR-003Configurable pseudonymisation, logged access
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 French teaching hospital of pale stone at first light, a courtyard and tall windows; no people.

See ZINOS against French rules.

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