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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

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

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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