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Clinical validation

TEF-Health Service
Virtual
Pricing/Discount Options: Call #2

Service Description

OVERVIEW Assessment of AI solutions within real-world clinical environments by healthcare and IT professionals. This service covers the entire testing lifecycle: from formative assessments (iterative clinician feedback to refine the product and its integration) to summative validation (structured performance testing against predefined KPIs). It ensures AI solutions are safety and clinically accurate, and optimized for user adoption, workflow efficiency and security.

HOW CAN THE SERVICE HELP YOU ? Clinical validation is a critical step in demonstrating that an AI solution performs effectively in real healthcare settings. This service enables developers to evaluate their solution under routine clinical conditions, collect structured feedback from healthcare professionals, identify potential usability or workflow integration issues, and measure performance against predefined objectives. The resulting evidence supports product improvement, facilitates regulatory preparation, and increases confidence among healthcare providers and end users.

HOW WILL THE SERVICE BE DELIVERED ? The validation process begins with the definition of the clinical objectives, evaluation protocol, target users, and key performance indicators (KPIs). The AI solution is then deployed within representative clinical environments, where healthcare professionals and IT experts perform structured evaluations throughout routine clinical activities. Formative assessments provide iterative feedback to improve the solution, while summative evaluations measure its clinical and technical performance against predefined criteria. At the end of the process, the customer receives a comprehensive validation report with findings and recommendations.

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: • Definition of clinical validation objectives and evaluation protocols. • Development of validation plans and performance indicators. • Deployment of AI solutions within representative clinical environments. • Formative evaluations involving healthcare professionals to improve usability and workflow integration. • Summative validation based on predefined clinical and technical KPIs. • Assessment of clinical performance, safety, reliability, interpretability, and user acceptance. • Evaluation of workflow integration, operational impact, and technical performance. • Documentation of validation results and recommendations to support regulatory and market readiness.

SERVICE CUSTOMIZATION The service can be tailored to the maturity, intended use, and clinical context of the AI solution based on customer’s needs: • the target clinical specialty or healthcare setting; • the validation objectives and evaluation criteria; • the performance indicators and success thresholds; • the duration and scope of the validation activities; • the level of involvement of healthcare professionals and end users. The final validation protocol is adapted according to the characteristics of the AI solution, the intended clinical application, available infrastructure, internal policies and requirements, regulatory approvals, and legal constraints.

Offerings: Testing Conformity & Compliance Algorithms/Models (transparency, accountability, privacy, fairness, reliability, etc.)
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Provider & Contact

Provider Country Belgium
Organisation Website https://www.humani.be/humani/projets-ia/
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 Study protocol, regulatory requirements, and relevant clinical documentation (e.g., informed consent forms, investigator brochures)
Service Outputs Comprehensive reports
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)