Evaluation of dataset needs
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 & Contact
Provider Organisation
HUMANI SC - Hospital network (HUMANI)
Provider Country
Belgium
Published Email
tefservices@humani.be
Billing: per hour
Full Price
€63-265 EUR
Reduced Price
€48-202 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
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)