CORDIS · GENz-trials
GENz-trials: Revolutionizing Clinical Trials to Optimize Assessment of Healthcare Innovations
- Code
GENz-trials- Programme
- HORIZON
- Call
HORIZON-JU-IHI-2025-09-05-single-stage- Status
- SIGNED
- Period
- 2026-01-01 – 2030-12-31
Official data · CORDIS · synced 2026-10-17 10:16 · official record
Participants
| Organisations | Role | Country | Grant |
|---|---|---|---|
| ARISTOTELIO PANEPISTIMIO THESSALONIKIS | coordinator | EL | 565 000 € |
| VIANEX A.E. ANONYMOS EMPOROVIOMICHANIKI TOURISTIKI XENODOCHEIAKI KAI NAFTILIAKI ANONYMOS ETAIREIA | participant | EL | 1 000 000 € |
| UBITECH LIMITED | participant | CY | 1 000 000 € |
| AINIGMA TECHNOLOGIES | participant | BE | 912 000 € |
| KATHOLIEKE UNIVERSITEIT LEUVEN | participant | BE | 553 000 € |
| ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK | participant | FR | 540 000 € |
| IQVIA HELLAS TECHNOLOGY SOLUTIONS SINGLE MEMBER SOCIETE ANONYME | participant | EL | 510 000 € |
| Hict | participant | BE | 500 000 € |
| FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS | participant | IT | 400 000 € |
| ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS | participant | EL | 300 000 € |
| ETOS LIGAL SALYUSHANS LLC | participant | BG | 200 000 € |
| INNOVATION, INFORMATION, INTELLIGENCE EVOLUTION IKE | participant | EL | 200 000 € |
| NOVA DIMENSION EOOD | participant | BG | 180 000 € |
| FWDFASTER AI RESEARCH BV | participant | NL | 150 000 € |
| ELPEN PHARMACEUTICAL CO INC | participant | EL | 100 000 € |
| DAIICHI SANKYO EUROPE GMBH | participant | DE | 0 € |
Description
GENz-trials, a private-public funded pan-European consortium, proposes a next-generation clinical trial framework that integrates data science, automation, and simulation technologies to transform how trials are designed, conducted, and evaluated. The strategy builds on three interlinked innovation pillars. i) Automation of critical trial workflows using generative AI for personalized informed consent, protocol drafting, monitoring, and regulatory submission, thereby reducing administrative burden and expediting trial initiation. ii) Artificial Intelligence (AI)-driven patient recruitment by analysing large-scale Electronic Health Records (EHRs), and real-world datasets to optimize matching between patients and trial protocols, improving enrolment rates, inclusiveness, and avoidance of patient dropout. iii) integration of Digital Twins (DTs) and Synthetic Control Arms (SCAs) for protocol optimization through in-silico simulation and enabling ethically sound alternatives to placebo groups, using real-world data to construct robust comparators with fewer enrolled participants. GENz-trials will serve as a platform for boosting innovation in the assessment of the added value of integrated healthcare solutions, providing a flexible and data-rich environment to evaluate not only pharmaceuticals, but also diagnostics, digital health tools, and therapeutic combinations, ultimately strengthening health technology assessment, regulatory decision-making, and reimbursement strategies. The GENz-trials framework will be unfolded in three phases: development of core tools; retrospective emulation of historical trials; and prospective validation through a Phase IV clinical equivalence trial comparing a generic anticoagulant with its branded counterpart. Through this phased strategy, GENz-trials aims to establish a more ethical, inclusive, and cost-effective paradigm for clinical research, accelerating the evaluation and deployment of life-saving healthcare innovations.
Official data · CORDIS · synced 2026-10-17 10:16 · official record · Licence: © European Union, CC BY 4.0 (Commission reuse policy).