GENz-trials

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, (ii) AI-driven patient recruitment by analysing large-scale Electronic Health Records (EHRs) and real-world datasets to optimize matching between patients and trial protocols, and (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. The GENz-trials framework will be validated in three phases: development of core tools, retrospective emulation of historical trials, and prospective validation through a Phase IV clinical equivalence trial.

ITI-CERTH plays a central role in the GENz-trials project, leading the development of AI and natural language processing (NLP) tools in WP3. Specifically, CERTH leads tasks T3.1 (AI-powered clinical trial protocol generation and eConsent systems) and T3.2 (AI-powered systematic review toolkit), leveraging models such as BioGPT, LegalBERT, and RAG pipelines. Additionally, CERTH contributes to the integration of the GENz-trials platform (T3.5), the deployment and evaluation of AI tools in real-world clinical trials (WP6), cost-effectiveness and HTA assessments (T7.3), as well as exploitation activities and IPR management (T7.4).

Consortium

Aristoteleio Panepistimio Thessalonikis (AUTH), Greece
Vianex A.E., Greece
Elpen Pharmaceutical Co Inc, Greece
Daiichi Sankyo Europe GmbH, Germany
IQVIA Hellas Technology Solutions, Greece
Hict, Belgium
Ethniko Kentro Erevnas kai Technologikis Anaptyxis (CERTH), Greece
Katholieke Universiteit Leuven (KUL), Belgium
ECRIN European Clinical Research Infrastructure Network, France
Ainigma Technologies, Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Italy
FWDFaster AI Research BV, Netherlands
Ubitech Limited, Cyprus
Innovation, Information, Intelligence Evolution IKE (I3VO), Greece
Etos Ligal Salyushans, Bulgaria
Nova Dimension EOOD, Bulgaria