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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

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

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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