Founded in 2001, Vicomtech is a private, non-profit applied research center based in San Sebastián and Bilbao, Spain. It supports companies and institutions in the R&D of new products and services to enhance competitiveness and tackle societal challenges. The Digital Health and Biomedical Technologies department has 40 researchers focusing on Digital Health, Precision Medicine, Biomedical Devices, Image Analysis and Big Data. Vicomtech is a key player in EU-funded R&I projects, driving multisectorial technological advancements, and is ISO-13485 certified for R&D of software/AI-based medical devices.

Vicomtech, with strong expertise in EU-funded projects, coordinates CARAMEL. Vicomtech will be in charge of the overall project management, coordinate the AI modelling efforts leading to the new personalised prevention strategy, take part in the development of the CARAMEL digital platform and support the planned 4 clinical studies.

A3Z advanced, founded in 2016, specializes in supporting manufacturers in the pharmaceutical, cosmetics, nutraceuticals, and medical products industries. With a focus on Quality Assurance (QA) and Regulatory Affairs, particularly for AI-driven medical devices, the company aims to enhance compliance and efficiency. It offers Quality System Assurance services to optimize clients’ systems to meet standards like GxP and ISO certifications. Since 2020, it has expanded into Regulatory Affairs for medical devices. Additionally, it provides Analytical Methodology Development and validation based on ICH and USP guidelines. Backed by a founding team with 25 years of experience, A3Z advanced drives innovation and ensures regulatory adherence.

A3Z as partner, which is a consultancy company specialized in regulation of software as a medical device. We focus on ensuring that artificial intelligence models for the diagnosis of cardiovascular diseases are developed in accordance with the specific quality regulations applicable to this type of medical devices.

Keralty (KER) is transforming global healthcare, operating in 10 countries and 700+ cities, impacting over 10 million people. With nearly 50 years of experience, KER built an innovative integrated model prioritizing individuals, families, and communities, ensuring compassionate, high-quality, and sustainable care. Their network includes a primary care and specialized network: 12 hospitals, 91 labs, 7 emergency units, 464 healthcare centers, 59 dental clinics, and 32 optical centers. A team of 28,966 professionals, including 9,692 physicians, delivers over 11 million annual services—90% in primary care—plus home visits, telehealth, and patient discharges, positioning Keralty as a global healthcare leader.

Keralty will join the CARAMEL project as a Clinical Site, contributing to clinical data collection for predicting and preventing cardiovascular diseases in women aged 40-60. Keralty will conduct surveys, interviews, workshops, focus groups, recruitment, clinical assessments, follow-ups, and gather data from electronic health records and diagnostic tools.

BioKeralty (BK) is part of Keralty Group, driving research in chronic diseases, regenerative and personalized medicine, cancer, AI/digital health, social and community care. Guided by Keralty’s health model, it connects the European Research Area with healthcare realities in Keralty’s service regions. Since 2009, BK has fostered open innovation through global partnerships, advancing knowledge and technology for the benefit of users and society. Its focus in European research is reflected in important achievements within Horizon programs, solidifying its role in health innovation. Through continuous progress, BK strives to improve healthcare through cutting-edge research and collaboration.

Biokeralty, as an Affiliated Entity of beneficiary KERALTY, will support KER mostly in WP4, in the implementation of CARAMEL-WOMEN study and in WP13 coordinating the health economic studies of the potential integration of CARAMEL stratification model in T13.3.

Founded in 2019, PARTICLE is a Portuguese SME with a technology drive that provides secure systems and mobile applications for remote patient monitoring, disease self-management and health prevention, leveraging the IoT paradigm and supporting high volumes of data exchange. PARTICLE’s solutions integrate connected medical devices and wearables and deliver advanced monitoring capabilities, robust communication protocols, secure cloud platforms and Big Data architectures that enable advanced analytics and artificial intelligence, upholding innovative interoperability, security and privacy features.

PARTICLE leads CARAMEL’s Work Package 5 on the multi-source collection of health data to support CARAMEL’s clinical studies. PARTICLE coordinates the CARAMEL data capture pilot and is responsible for implementing the lifestyle questionnaire, the design of the user interfaces and the CARAMEL mobile App ecosystem.

iBreve develops self-care solutions that empower prevention and promote healthy living. Our patent-pending wearable technology analyzes respiratory patterns in real-time, enabling applications for stress management, remote monitoring and chronic disease management. Manufactured in the EU, our devices combine advanced AI-driven analysis with a sustainable design approach, ensuring benefits for both users and the planet.

Within CARAMEL, iBreve provide EU-made wearables designed for women, supporting observational and interventional studies in respiratory monitoring. Our solution provides tailored breathing and meditation for stress management and underpins data analysis and AI development.

Clinic Magdalena, founded in 1996, offers comprehensive cardiovascular care, guiding patients from diagnosis to treatment through conservative, interventional, and surgical options. With locations in Krapinske Toplice and Zagreb, along with Croatia’s first outpatient cardiovascular diagnostics center, it enhances accessibility to specialized care. As a teaching institution, they collaborate with J. J. Strossmayer University in Osijek and Pregrada High School. MAG is a contracted provider for the Croatian Health Insurance Fund (HZZO) and part of the national emergency PCI network, delivering 24/7 care for heart attack patients. Our commitment to quality and patient safety is reinforced by ISO 9001, ISO EN 15224, and Diamond Accreditation from Accreditation Canada.

The Magdalena Clinic, in collaboration with Megi, leads the development of the Megi Virtual Health Coach (VHC), integrating AI personalization and chatbot functionality for CVD risk education. It enhances message scheduling, develops multilingual support with LLMs, and coordinates an intervention study across five clinical sites. It also tests digital tools, monitors implementation, and contributes to CVD researches in menopausal women.

MEGI is a digital health company that offers an AI-powered virtual assistant designed to support individuals in managing hypertension and improving cardiovascular health. Their technology combines clinical knowledge, behavioral science, and personalized digital coaching to promote long-term adherence to healthy lifestyles. With a user-friendly interface and evidence-based content, MEGI empowers both patients and healthcare professionals through data-driven tools and remote monitoring solutions. The company focuses on delivering scalable, accessible, and personalized digital health interventions, aiming to reduce cardiovascular risk and improve health outcomes.

Within CARAMEL, MEGI is responsible for enhancing the Virtual Health Coach and developing the Self-Management App (smApp). It leads the CARAMEL interventional study (CARAMEL-IS), including the training of healthcare professionals, integration of care pathways in real-life settings, and deployment of self-management tools across clinical sites.

Founded in 1997, under the instructions of Professor of Endocrinology Irene Lambinoudaki specializes in clinical management of symptoms of menopause, osteoporosis, HRT. Also, our clinical site specializes in the evaluation of many examinations such as mammographies,TVUS, DEXA, Pap smears.

NKUA contributes as a clinical site in Greece. In the CARAMEL-WOMEN study, it supports the recruitment and clinical assessment of participants. NKUA is responsible for data collection, validation, and integration into the project’s common data model, ensuring high-quality clinical insights. Additionally, it provides expertise in gynaecological, endocrinological and cardiovascular health screenings.

The Andalusian Health Service (SAS) is Andalusia’s public healthcare system, serving 8 million people. It manages 1,517 primary care centers and 49 hospitals, providing medical care, prevention, and health promotion. SAS uses Diraya, a unique electronic health record system that integrates patient information across all levels of care. Operated by the Andalusian Government, it ensures accessible, high-quality care within Spain’s public health system.

In CARAMEL, SAS is leading the retrospective study efforts and contributing to data harmonization and analysis. Specifically, SAS is responsible for the extraction of clinical data, supporting the alignment of datasets to a common data model, and conducting environmental data mapping. Additionally, SAS aids in the co-creation of digital tools, drafts protocols for prospective clinical studies, and actively participates in their implementation​.

Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI) supports biomedical research and innovation in Andalusia, Spain. It collaborates with hospitals, universities, and research centers to promote scientific progress and healthcare improvement. FISEVI manages research projects, funding, and technological development, facilitating the transfer of knowledge to clinical practice. Backed by the Andalusian Government, it enhances the region’s healthcare system by fostering innovation and excellence in medical research.

FISEVI contributes to both retrospective and prospective clinical studies. It leads the writing of study protocols, extracts SAS clinical data, and supports harmonization to a common data model. FISEVI assists in data analysis, mapping environmental data, and co-creating tools. It also helps draft protocols for future studies and actively participates in their implementation.

Social IT is an innovative SME specializing in the development of cutting-edge ICT solutions. Its mission is to implement innovative and flexible technology solutions, with particular attention to users and their needs. Core competencies include the development of personalized software, cloud and web applications, and system integration. Extensive experience in European projects has facilitated the continuous development of expertise through intensive research and innovation activities.

In CARAMEL, SIT leads the communication, dissemination, and exploitation strategy, ensuring broad stakeholder engagement. Moreover, SIT is responsible for developing the CARAMEL Prevention Portal, enhancing women’s health literacy and self-assessment for personalized prevention.

Trinity College Dublin, founded in 1592, is Ireland’s premier university and one of Europe’s oldest. Located in Dublin’s city centre, its 47-acre campus blends historic buildings with cutting-edge facilities. Trinity offers a world-class education across Arts, Humanities, Social Sciences, Engineering, Science, and Health Sciences, with excellence in research and scholarship at its core. It leads in multidisciplinary research, housing Ireland’s first Nanoscience institute (CRANN) and the Trinity Long Room Hub for Arts and Humanities. The Library, home to the Book of Kells, is Ireland’s largest research library. Trinity fosters accessibility and entrepreneurship, producing notable alumni, including Nobel laureates.

Trinity College Dublin leads WP4 (design and conduct of survey, interviews, and analyses), establishment of and lead on end-user committee, a co-creation study with women determining their menopause and CVD determinants, and co-design of digital platform. TCD supports IMPACT work packages, collaborating on communication, dissemination, engagement, awareness, networking, and commercial exploitation of innovations.

TREE Technology SA is a Spanish R&D-focused SME delivering ICT solutions powered by Big Data, AI and Cybersecurity across various sectors, including healthcare, finance, security, public services, and industry. Operating within an open innovation model, TREE helps clients optimize processes and enhance business outcomes. The R&D unit key research areas include Machine Learning, Analytics, Computer Vision, Cognitive Systems, Distributed Computing, Visual Analytics, and Privacy & Security.

TREE Technology will be mainly involved in leading the activities related to the develop of the CARAMEL Digital Platform and the modelling of AI models from Risk Factors as collected in existing cohorts, the analysis of the data collected by wearables to extract hidden knowledge and model proptotyping specific notifications, reminders or recommendations to the study participants.

VUL Santaros Clinics is one of the largest hospitals in Lithuania, offering top-level specialised healthcare services as well as conducting ongoing educational and scientific research. The hospital provides essential and planned care delivered by highly qualified doctors and nurses. Additionally, experienced consultants at the secondary and tertiary levels offer outpatient consultations and refer patients for further treatment when needed.

In CARAMEL, Santaros Clinics contributes with its clinical expertise in cardiology and other fields to support study design, data quality, and result interpretation. It provides retrospective data for AI model development and validation. Additionally, Santaros Clinics plays a vital role in the CARAMEL-OS and CARAMEL-IS studies, handling participant recruitment, data collection, and protocol adherence.

CIC bioGUNE is a leading Spanish research institution specializing in Life Sciences. Located in the Bizkaia Science and Technology Park in Derio, Bilbao, it operates conducting cutting-edge multidisciplinary research in Chemistry, Mathematics, Biology, and Biomedicine. CIC bioGUNE is equipped with advanced genomics, proteomics, and metabolomics platforms. The recent installation of a 1 GHz Bruker Spectrometer has placed its NMR facility, recognized as a Unique Scientific and Technical Infrastructure (ICTS). These resources, combined with a highly skilled scientific team, drive impactful advancements benefiting healthcare, industry, and the global research community.

CIC bioGUNE will participate in the analysis of metabolites and lipoproteins in biological samples using NMR. The center owns two 600 MHz spectrometers specifically dedicated to the metabolomic study of urine and serum/plasma, ensuring measurements with high standards of quality and reproducibility. It also has cohort of NMR data, from which valuable information may be extracted.

ASCIRES, Spain’s leading biomedical group in Genetics, Diagnostic Imaging, and Nuclear Medicine, is also a benchmark in Radiation Oncology. With over 600 healthcare professionals, it operates 20 Biomedical Clinics across the Valencian Community, Madrid, and Catalonia. With more than 50 years of experience, ASCIRES reinvests 15% of its profits in R&D, driving advancements in precision medicine. This commitment enables the continuous development of AI-driven biomarkers and diagnostic algorithms that integrate genomic, clinical, and imaging data.

ASCIRES, with a strong experience in imaging data projects, will act as a data provider. Thanks to its huge database of clinical images, ASCIRES will provide clinical images (cMRI, DXA, US and CTC) for the CARAMEL retrospective study. These images will be used to develop artificial intelligence-based models to find specific biomarkers of interest.

Heart Rhythm Ireland (HRI) is a leading provider of digital cardiac care solutions, specializing in the management of patients with implanted cardiac devices. As the National Registry for Cardiac Device Implants in Ireland, HRI leverages real-world data from over 85,000 cardiac devices to support clinical decision-making and improve patient outcomes. HRI integrates advanced data analysis with clinical workflows, ensuring compliance with European MDR regulations. HRI is actively developing AI-driven predictive models to enhance risk detection and support innovation in cardiac care, collaborating with hospitals, clinicians, and industry partners to drive these advancements.

Heart Rhythm Ireland (HRI) contributes to CARAMEL by leveraging its cardiac device dataset to develop AI-driven predictive models for early risk detection in women aged 40-60. Using real-world data from 85.000 devices, HRI analyzes key cardiac metrics to enhance clinical decision-making and improve patient outcomes. These insights support AI-driven strategies for earlier intervention and prevention.

Dublin City University was founded in 1981 and it now comprises over 17,500 students including over 2600 postgraduate students, of whom c. 800 are research students spead across a multi-campus university just north of Dublin City Centre. DCU, Ireland’s top ranked University in the Times Higher Education ‘Young University’ rankings and 59th globally, has a mission to transform lives and societies. Through education, research and innovation, we are focused on delivering real impact, and addressing global challenges in collaboration with our partners and stakeholders. 90% of our courses have paid, relevant work experience or work placement and DCU is ranked No 1 in Ireland and 23rd globally for graduate employment rate.

DCU, as Ethics expert, chairs the Gender, Legal, Ethics and Data Committee, leads tasks related to the ethical conduct of CARAMEL research and contributes to WP4 (Analysis of CVD risk factors and self-assessment tools), WP5 (data), WP11-13 (ethical design of CARAMEL studies) and WP14-16 (impact), in particular developing training materials and raising awareness about female cardiovascular health.

Tampere University was formed in 2019 when the University of Tampere and Tampere University of Technology merged. It now serves nearly 20,000 students with over 2,800 staff. Tampere University’s strong collaboration with Tampere University Hospital offers unique opportunities for biomedical research and clinical trials. Tampere University also offers robust programs in technology, humanities, and social sciences, fostering a dynamic environment for cross-disciplinary innovation.

Tampere University plays a clinical role in CARAMEL by collecting samples and data in collaboration with the large-scale, pan-European CoroPrevention trial. This new resource directly supports CARAMEL activities while also enabling broader future research in cardiovascular disease.

ULMA Medical Technologies develop cutting-edge healthcare solutions that enhance efficiency and drive innovation across clinical workflows. Our technology seamlessly integrates AI models, data management platforms, and medical imaging devices, enabling early disease detection and optimizing clinical decision-making across diverse healthcare settings. By enhancing diagnostic precision and patient monitoring, our holistic approach empowers healthcare professionals with reliable, data-driven insights—improving patient outcomes, maximizing resource efficiency, and advancing the standard of care.

In CARAMEL, ULMA will deploy advanced retinal imaging devices and implement AI-driven analytical tools across six leading European clinical institutions, enhancing early detection and prevention strategies for CVD risk factors in women.

Ben-Gurion University (BGU) of the Negev is one of Israel’s leading research universities and a global leader in many fields. It has around 20,000 students and 4,000 faculty members across its faculties: Engineering Sciences, Health Sciences, Natural Sciences, Humanities and Social Sciences, Business and Management, Medicine, Advanced Graduate Studies, Brain Sciences and Cognition, Sustainability and Climate Change, and Desert Studies. With over 100,000 alumni, BGU plays a key role in research, industry, healthcare, the economy, society, culture, and education in Israel, driving innovation, entrepreneurship, and groundbreaking discoveries that shape the country’s future.

Within the CARAMEL project, BGU is responsible for the development and application of tools for the discovery of frequent temporal patterns and longer trajectories in the patients’ records, and for their use as features for cardiovascular risk classification, prediction, and clustering. Moreover, it takes care or their formal representation, for the purpose of application, of clinical guidelines, and assessment of the quality of adherence to them.

SmartNanoSense Innovation (SNSI) specializes in non-invasive sensing tools for diagnostics and health monitoring. Combining micro- and nanotechnology with AI and IoT, SNSI delivers real-time solutions for biomarker detection and physiological monitoring, advancing healthcare, consumer electronics, and environmental applications.

SNSI contributes to the CARAMEL project by developing and manufacturing battery-free skin patches equipped with NFC technology and chemical sensors for detecting cardiovascular disease (CVD)-related biomarkers. Additionally, SNSI plays a role in health technology assessment and regulatory compliance.

Biogipuzkoa (BIO) is the leading Health Research Institute in Gipuzkoa within the scope of Osakidetza – Basque Health System. The Institute Founded in 2008, and accredited by the Carlos III Health Institute. It unites 32 research groups, 450 researchers in primary care, cardiology, public health and epidemiology, and digital health areas. The Institute promotes translational research focused on patients and the general population, putting its multi-institutional and interdisciplinary collaborative structure at the service of improving the health of citizens.

BIO’s role in CARAMEL involves co-creating the CVD-RA framework (WP4), providing Real World Data (RWD) for AI model development (WP5-8), leading the multisite CARAMEL-OS study (WP11-12), and updating the final stratification model (WP13) for healthcare integration and public health policies.

Timelex (TLX) is a niche law firm specializing in IT law, privacy & data protection (GDPR), intellectual property, and media & electronic communications. It provides legal support to innovators, from SMEs to multinationals, consortia, and academic institutions. Timelex is active in Horizon 2020 and Horizon Europe projects, often leading legal work packages to ensure compliance with privacy, data protection, IP, AI, and medical regulations. With extensive experience, Timelex helps research and innovation projects navigate complex legal and ethical requirements.

Within CARAMEL, Timelex serves as the legal and ethical advisor and a member of the Gender and Ethics Committee. It ensures GDPR, AI, health, and data-sharing compliance. Key tasks include drafting privacy policies, informed consent, DPIAs, joint controllership agreements, and reviewing clinical protocols. Timelex will deliver key legal and ethical reports at M36 and M54.