TNO, Radboud UMC, and EATRIS are jointly developing Harmonise-D, a flagship R&I initiative in digital biomarkers aimed at accelerating the translation, validation, and adoption of digital biomarkers and digital endpoints into research, clinical studies, and healthcare practice.
Harmonise-D focuses on key technical components, including secure and privacy-preserving data-sharing infrastructure, access to benchmark datasets, and the development of standardised, regulatory-aligned evidence generation pipelines. To support this initiative, we are seeking candidate projects to be included as flagship demonstrators. Selected demonstrators will benefit from tailored support to further develop their Digital Biomarker through co-development with the core team and its expertise.
This call is open to projects across Europe, including applicants from academia, SMEs and healthcare providers. We are seeking demonstrators focused on Digital Biomarkers. Proposals may be submitted at different maturity stages, including:
- Validation Readiness (Prototype and Technical / Clinical Validation Planning) (TRL4-5) Projects that have a clear functional hypothesis and early proof-of-concept for a Digital Biomarker or monitoring approach and require structured validation, regulatory engagement, clinical study design support, or evidence generation planning.
- Implementation & Adoption (Late Validation / Deployment) (TRL5-6) Projects that have generated evidence and require support for adoption pathways, interoperability, re-purposing, regulatory qualification strategy, or integration into healthcare systems of a Digital Biomarker
Demonstrators will be selected based on functional relevance, the ability of the project to support the co-development of the platform, and maturity level.
If you wish to submit your project, please fill out this form. Submission deadline: by 27 April 2026. For more information, write to Emanuela Oldoni.
