Provision of structured clinical datasets
Service Description
OVERVIEW Provision of structured patient datasets organized in cohorts and mapped to international standards upon request. This service ensures technical interoperability and facilitates multicenter databases validation by providing ready-to-use data for large-scale clinical evaluation.
HOW CAN THE SERVICE HELP YOU ? Healthcare AI developers often face challenges in accessing high-quality clinical data that are standardized and suitable for multicenter evaluation. This service provides structured datasets that reduce the time and effort required for data preparation, enabling organizations to focus on developing, validating, and benchmarking AI algorithms. It supports interoperability between institutions and facilitates compliance with internationally recognized data models, making clinical validation more efficient and reproducible.
HOW WILL THE SERVICE BE DELIVERED ? Datasets are extracted, curated, pseudonymized or anonymized as appropriate, and transformed into the requested interoperability standard (see below). Datasets are provided performed through secure data transfer mechanisms (using the secure FileCap software solution) or within approved secure computing environments, depending on governance requirements. Delivery timelines depend on the complexity of the requested cohort, data availability, and regulatory approvals.
PROVIDER DESCRIPTION HUmani CHU Charleroi-Chimay is a hospital network composed of five general and specialized hospitals and 8 polyclinics offering healthcare services in more than fifty medical and surgical specialties. Located in Belgium, at the heart of Europe, we are strongly committed to clinical research with the support of a dedicated Clinical Research Unit offering Clinical Research Organization (CRO)-like services.
TECHNICAL DETAILS The service includes: • Identification and extraction of eligible patient cohorts from hospital information systems. • Clinical data quality assessment and curation. • Data standardization and semantic mapping to OMOP CDM, HL7 FHIR, DICOM, etc. • Generation of structured datasets from real-world clinical data. • Support for multicenter data harmonization and interoperability. • Preparation of datasets suitable for AI development, validation, benchmarking, and clinical performance evaluation. • Compliance with applicable GDPR requirements and institutional data governance procedures.
SERVICE CUSTOMIZATION The service can be tailored according to customer's needs: • cohort inclusion and exclusion criteria; • clinical domains of interest; • requested interoperability standard (OMOP CDM, HL7 FHIR, DICOM, etc.); • data elements and level of granularity; • delivery format and secure access modality. The scope of the service depends on data availability, Internal policies and requirements, regulatory approvals, and legal constraints.
Provider & Contact
This price is based on the less qualified human resource who may perform the service. Additional costs of 0.25€-0.70€/data may also be incurred. The final price will be determined in the contract between the service provider and the applicant.
Operational Details
- 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)