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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.

HUmani can provide this service à la carte or with full sponsor role.

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
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Provider & Contact

Provider Organisation HUMANI SC - Hospital network (HUMANI)
Provider Country Belgium
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Billing: per hour
Full Price €70–83 EUR
Reduced Price €54–63 EUR

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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