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Clinical Research Services - Data management

TEF-Health Service
Physical Consulting
Unique Identifier: e03cbc66-fe47-416a-8504-10dccbbff976

Service Description

OVERVIEW : Data Management services consist of the planning, collection, validation, processing, and maintenance of study data throughout the conduct of a clinical investigation. Our service covers the design the electronic Case Report Form (CRF), Paper-CRF design and printing, database design and set-up, the review and validation of clinical data to identify inconsistencies, missing information, and potential errors electronic, the generation, management, and resolution of data queries with study sites, provision of clean and validated datasets for statistical analysis.

HOW CAN THE SERVICE HELP YOU ? : This service helps the SME ensuring the integrity, quality, and completeness of the clinical data from your clinical investigation, by detecting and resolving data discrepancies in a timely manner, maintaining data traceability and regulatory compliance, supporting reliable statistical analyses and study conclusions, and facilitating the preparation of clinical study reports and regulatory submissions.

HOW WILL THE SERVICE BE DELIVERED ? : The service is delivered by HUmani’s Clinical Research Unit through various meetings (face-to-face or remote) with the SME, and other relevant stakeholders where needed.

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 in compliance with Guideline for Good Clinical Practice ICH-GCP E6(R3), the ISO 14155:2026 standard, the European Medicine Agency guidelines on biostatistics, and the EU regulation MDR 2017/745, and HUmani standard operating procedures.

SERVICE CUSTOMIZATION : This service is tailored to the specific needs of the SME and of the clinical investigation, based on the availability of the clinical investigation plan (CIP/study protocol). This service may be provided by HUmani either as part of its role as the full sponsor of your investigation study, 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 Medical device documentation; Feasability report; Preliminary synopis; Project draft; Clinical investigation protocol
Service Outputs Clinical investigation protocol; e-/paper- CRF; Database; CRF completion guidelines
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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