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Clinical Research Services - Initial feasibility study

TEF-Health Service
Physical Consulting
Unique Identifier: 98d10bc4-6d5b-4678-bba6-bf04b2ff797c

Service Description

OVERVIEW : HUmani provides a structured assessment of the SME needs to clarify the key elements of the clinical investigation proposal, from scientific, medical, operational and regulatory perspectives, to determine whether it matches HUmani’s offerings and how it can be successfully implemented and performed at HUmani.

HOW CAN THE SERVICE HELP YOU ? : This service helps the SME to turn his initial clinical research proposal into a structured clinical investigation allowing the identification of the cross-discipline professionals required to prepare and/or perform it. Under HUmani’s guidance, study design, endpoints, sample size, methodology, applicable regulations, etc. are reviewed to optimize the initial proposal, and draft a clinical investigation synopsis that may serve as a basis for the Clinical Investigation Plan (CIP/study protocol), human resources planning and study budget estimation.

HOW WILL THE SERVICE BE DELIVERED ? : The initial investigation feasibility services is completed through face-to-face or remote meetings with the SME and identified stakeholders in a 3-steps procedure: 1. An initial meeting to understand the actual SME needs and clarify the objectives of the clinical investigation proposal. 2. HUmani identifies the most appropriate healthcare professional(s) required for preparing (and/or) conducting the clinical investigation at HUmani. 3. When clinical partners and study objectives are set, HUmani provides a quotation* for the development of the study synopsis. * This quotation does not apply to the final clinical investigation protocol, which incorporates key elements (study subjects/visits numbers, procedures, etc.) that are not known at this stage.

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 : This service is delivered in compliance with HUmani’s standard operating procedures, including the full execution of a Confidential and Non Disclosure Agreement (CNDA) between the parties before the service is provided.

SERVICE CUSTOMIZATION : This service is tailored to the SME needs, and might be delivered by HUmani either as part of its role as the full sponsor of your investigation, or on an “à la carte” basis.

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 76–287 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 Clinical investigation protocol; Investigation team proposal; Budget draft
Service Outputs Clinical study agreement proposal; Budget proposal
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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