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Clinical Research Services - Clinical operations - Study monitoring

TEF-Health Service
Physical Consulting
Unique Identifier: ed4bea1a-d7b5-4e49-be74-fa0b068bf493

Service Description

OVERVIEW : Study monitoring is a sponsor's legal responsibility, which covers the process of regularly overseeing a clinical investigation all along its performance by the investigator and the study team, from study initiation to study closure, to ensure that it is conducted correctly, safely, and in compliance with the study protocol, applicable regulations, and Good Clinical Practice (GCP) guidelines. Study monitoring is a quality control that applies to all aspects of a clinical investigation at the study site (investigator, study team, study conduct, subjects, device, etc.).

HOW CAN THE SERVICE HELP YOU ? : This service helps the SME by ensuring that the clinical investigation is conducted in compliance with the approved protocol, applicable regulations, Good Clinical Practice (GCP), and quality requirements. It provides independent oversight of study activities, helps identify and resolve issues early, and ensures that the collected data are accurate, complete, and reliable. This service may also be performed in preparation for a site audit or regulatory inspection.

HOW WILL THE SERVICE BE DELIVERED ? : Study monitoring is performed by qualified study monitors from the HUmani’s Clinical Research Unit during on-site monitoring visits throughout the duration of the investigation, from study initiation to study closure and archiving: site qualification/selection visit (SSV), site initiation visit (SIV), site monitoring visits (SMV), site close-out visit (SCV).

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 performed through regular review of study activities, documentation, and data, with reference to the guidelines for Good Clinical Practice (GCP E6 R3), the ISO 14155:2026 standard; EU regulations 2017/745 (MDR), 2016/679 (RGPD), Belgian laws and Royal Decrees, HUmani 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 Feasability report; Preliminary synopis; Project draft; Study protocol
Service Outputs Procedure reports
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)
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