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Clinical Research Services - Biostatistics

TEF-Health Service
Physical Consulting
Unique Identifier: aebf8ca0-fbe8-4a91-9e10-f37b64b1c32c

Service Description

OVERVIEW : This service covers all statistical aspects of a clinical study, throughout the entire clinical investigation lifecycle, from the preparation of the clinical investigation plans (protocol) to the clinical study report, including Statistical Analysis Plan (SAP), database consistency checks, database lock, interim/final data analysis, Statistical Analysis Report (SAR).

HOW CAN THE SERVICE HELP YOU ? : This service helps the SME by ensuring that the clinical investigation is scientifically valid and capable of producing reliable and interpretable results.

HOW WILL THE SERVICE BE DELIVERED ? : This service is delivered by a HUmani’s physician-biostatistician, through face-to-face and/or remote meetings all along the entire clinical investigation lifecycle. It may be provided either as part of its role as the full sponsor of your investigation or on an “à la carte” basis, depending on SME needs.

PROVIDER DESCRIPTION : HUmani CHU Charleroi-Chimay is a hospital network composed of five general and specialized hospitals and 8 polyclinics offering healthcare services in more than fifty medical and surgical specialties. Located in Belgium, at the heart of Europe, we are strongly committed to clinical research with the support of a dedicated Clinical Research Unit offering Clinical Research Organization (CRO)-like services.

TECHNICAL DETAILS : The work will be conducted in accordance with the ICH Guideline for Good Clinical Practice (GCP) E6(R3), ICH E9, European Medicine Agency guidelines on biostatistics, EU regulation MDR 2017/745 and the ISO 14155:2026 standard.

SERVICE CUSTOMIZATION : The service can be customized according to the SME’s specific needs, based on the availability of the following information: study objectives and design, primary endpoint, expected treatment effect (or performance target), variability or event-rate assumptions, significance level (α), desired power, expected dropout rate, planned analysis population.

Service categories: 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 287 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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