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Clinical Research Services - Clinical operations - Project assessment

Physical
Unique Identifier: 1350817d-0a0f-4350-8fbe-0298b6cac353

Service Description

Confidential and Non Disclosure Agreement (CNDA) signature. Listening to clinical research needs. Analyzing the international/national legal and ethical framework (laws, regulations, and ethical principles in force). Liaison with Competent Authorities (CA), experts, key-opinion leaders (KOLs), etc. (where needed). Identifying the necessary cross-discipline professionals (inner partners and external providers or vendors). Proposing comprehensive and customized solutions to optimize SMEs clinical research proposals.

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 €70-91 EUR
Reduced Price €54-70 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 CNDA signed; Medical device documentation; Project presentation (SME needs and expectations)
Service Outputs Feasability report; Research team proposal; Preliminary synopis; Project 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)
  • ISO 14155
Comments  

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