Objective
GENz-trials 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.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs
- social sciences sociology industrial relations automation
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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HORIZON.2.1.7 - Innovative Health Initiative
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-JU-IHI-2025-09-single-stage
See all projects funded under this callCoordinator
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
546 36 THESSALONIKI
Greece
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.