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Evaluation of dataset needs

Consulting
Pricing/Discount Options: Call #2
Unique Identifier: fecf1a14-4495-445f-a55d-6f1994bb4687

Service Description

Access to clinical and data experts to identify dataset needs.

Offerings: Ethics & Regulatory Affairs Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support, etc.)
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 Project description
Service Outputs Evaluation report, recommendations for improvement, feedback from medical professionals
Service Standards
  • International guidance and norms (Good Clinical Practice (ICH-GCP), ISO14155, etc.), and Belgium national laws and royal decrees (loi du 7 mai 2004 relative aux expérmentation sur les êtres humains, loi du 22 décembre 2020 sur les dispositifs médicaux, AR 18-05-2021 relatif aux investigations cliniques de dispositifs médicaux, etc.)
  • Where applicable: EU regulations (AI Act, EU regulations 2017/745-746 and 2020/561 on medical devices (MDR), General Data Protection Regulation (GDPR), etc)

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