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Clinical Research Services - Data management

Physical
Unique Identifier: e03cbc66-fe47-416a-8504-10dccbbff976

Service Description

Protocol development/review support. Electronic Case Report Form (CRF) design and production. Paper-CRF design and printing. Database design and set-up. CRF completion guidelines.

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 Medical device documentation; Feasability report; Preliminary synopis; Project draft; Clinical investigation protocol
Service Outputs Clinical investigation protocol; e-/paper- CRF; Database; CRF completion guidelines
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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