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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
Billing: per hour
Full Price €70-83 EUR
Reduced Price €54-63 EUR
Pricing Detail

This price is based on the less qualified human resource who may perform the service. The final price will be determined in the contract between the service provider and the applicant.​

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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