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Clinical Research Services - Clinical operations - Implementation and performance

Physical
Unique Identifier: 47620c02-6766-477f-80c2-afdf8a79e861

Service Description

Performing all monitoring activities ensuring compliance to the clinical investigation plan and regulatory requirements: site qualification/selection visit, site initiation visit, site monitoring visits, site close-out visit, site audit/inspection support

Offerings: Testing Clinical (investigation, trial, etc.) Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation HUMANI SC - Hospital network (HUMANI)
Provider Country Belgium
Published Email tefservices@humani.be

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs Ethics Commitees favourable opinion; Competent authorities approval; Fully-executed clinical investigation agreement; Clinical investigation essential documents; Medical device documentation
Service Outputs Monitoring reports; Clinical investigation files completed ; Audit/inspection reports and reply to
Dependencies & Restrictions  
Certification Support  
Service Standards
  • Artificial Intelligence Act
  • Belgian national laws
  • EU regulations: Medical Devices
  • GDPR
  • IATA
  • International regulations: Good Clinical Practice (ICH-GCP)
Comments  

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