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Clinical Research Services - Clinical operations - Study performance

TEF-Health Service
Physical Consulting
Unique Identifier: 47620c02-6766-477f-80c2-afdf8a79e861

Service Description

OVERVIEW : Study performance is under the responsibility of the investigator. The investigator and the study team (co-investigator, study-nurses, study-coordinators, and other participating departments) are responsible for the day-to-day conduct of the clinical investigation at the study site in compliance with the approved clinical investigation plan (CIP/study protocol), applicable regulations, Good Clinical Practice (GCP) principles, and site standard operating procedures. Their responsibilities include participant recruitment and follow-up, informed consent obtention, conduct of study procedures, investigational device management, data collection, safety reporting, recording accurate and complete study data, and maintaining source documentation, while ensuring participant safety and welfare.

HOW CAN THE SERVICE HELP YOU ? : This service enables the SME to generate high-quality clinical evidence on the performance, safety, usability, and clinical benefit of their solution. It supports regulatory submissions, clinical validation, scientific dissemination, and market adoption while ensuring evaluation under real-world clinical conditions by qualified investigators and study teams.

HOW WILL THE SERVICE BE DELIVERED ? : This service is delivered through HUmani qualified investigators and dedicated study teams operating within its clinical sites, providing access to HUmani patient populations.

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 (CRU) offering Clinical Research Organization (CRO)-like services.

TECHNICAL DETAILS : This service is performed through regular review of study activities, documentation, and data, with reference to the guidelines for Good Clinical Practice (ICH-GCP E6 R3), the ISO 14155:2026 standard; EU regulations 2017/745 (MDR), 2016/679 (RGPD), Belgian laws and Royal Decrees, HUmani’s standard operating procedures, and the clinical investigation plan (CIP/study protocol).

SERVICE CUSTOMIZATION : This service is tailored to the specific needs of the SME and the clinical investigation, 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 76–90 EUR
Reduced Price 54–63 EUR

Operational Details

Service Inputs Ethics Commitees favourable opinion; Competent authorities approval; Fully-executed clinical investigation agreement; Clinical investigation essential documents; Medical device documentation
Service Outputs Monitoring reports; Clinical investigation files completed ; Audit/inspection reports and reply to
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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