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Clinical Research Services - Medical writing

Physical
Unique Identifier: c0091fe5-4ab7-466c-84cf-ea95f111cc17

Service Description

Creation and provision of essential documents required for clinical investigation implementation and performance: investigation protocol, synopis, Informed Consent Form, investigation agreement, logs, etc. Implementation of clinical investigation files : site master file, investigation sponsor files, etc.

Offerings: 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
Provider Logo

Provider & Contact

Provider Organisation HUMANI SC - Hospital network (HUMANI)
Provider Country Belgium
Published Email tefservices@humani.be
Billing: per hour
Full Price €70-265 EUR
Reduced Price €54-202 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 Essential documents : clinical investigation protocol; informed consent form; Logs; etc; Clinical investigation files (site master file; investigation sponsor file); clinical investigation agreement draft
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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