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Clinical Research Services - Biostatistics

Physical
Unique Identifier: aebf8ca0-fbe8-4a91-9e10-f37b64b1c32c

Service Description

Comprehensive biostatistics services led by a physician biostatistician, including calculation of sample size, power calculation, data randomisation and/or analysis, to support the data-driven assessment of AI solutions maturity. This service is tailored to support the design and production of Clinical Investigation Plans (CIP) and/or Reports (CIR), Case Report Forms (CRF), as well as structured pilot reports documenting the progress of AI solutions from Technology Readiness Level (TRL) 7 to 9.

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 €265 EUR
Reduced Price €202 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 Statistical analysis plans; Interim and final statistical reports; Study report; Clinical investigation protocol.
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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