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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.

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 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)
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