European Paediatric Translational Research Infrastructure

What European Paediatric Translational Research Infrastructure does

EPTRI is a European research infrastructure project focused on paediatric translational research — the development and validation of therapies, biomarkers, formulations, and clinical trial designs specifically for children. It is funded under the European Union's Horizon 2020 programme (design phase under Grant Agreement 777554) and operates as a non-commercial consortium of European research institutions, hospitals, and stakeholder networks rather than as a revenue-generating enterprise. Its core service scope spans the full paediatric translational pipeline: discovery science, preclinical validation, paediatric formulation development, biomarker qualification, and paediatric clinical trial design aligned with EMA Paediatric Investigation Plan requirements.

The infrastructure is designed to address a well-documented gap in European paediatric drug development — namely, the fragmentation of paediatric research capacity across Member States and the under-representation of paediatric populations in translational pipelines. EPTRI coordinates this capacity by acting as a single point of access for academic researchers, pharmaceutical sponsors, and regulators seeking paediatric-specific translational capabilities, and it aligns its workflow with complementary European research infrastructures including EATRIS (translational medicine), BBMRI (biobanking), ECRIN (clinical trials), ELIXIR (life-science data), INFRAFRONTIER (model organisms), Euro-BioImaging, and the European Paediatric Formulation Initiative.

Because EPTRI is a publicly funded infrastructure, its "business model" is grant-based rather than commercial: funding flows from the European Commission, national contributions, and in-kind support from participating institutions. The initiative is currently pursuing inclusion on the ESFRI roadmap and Horizon Europe programme to convert the design-phase consortium into a permanent, sustainably funded legal entity. As such, traditional revenue mechanics — pricing, ARR, customer acquisition cost, gross margin — do not apply; value is measured in research output, regulatory alignment, and service throughput rather than commercial sales.

Name

European Paediatric Translational Research Infrastructure

Legal name

EPTRI ivzw (European Paediatric Translational Research Infrastructure – Association Internationale Sans But Lucrative, EPTRI – AISBL)

Website

https://eptri.eu

Company type

Private

Founded year

2024

Operating status

Operating

Headcount range

11–50 employees

Short description

EPTRI is an EU-funded, non-commercial research infrastructure coordinating European paediatric translational research across discovery, preclinical, formulation, biomarker, and clinical trial design stages for academic and industry users.

Ownership category

akta.pro rank

Product category

Paediatric Translational Research Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro industry

PRIMARYHLAGAOAJ

Preclinical, Toxicology & Translational Science Staffing FSP

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Scientific Staffing & Functional Service Providers (FSP)

SECONDARYHLAGAOAA

Clinical Operations & Monitoring FSP (CRA/CTM/Start-up)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Scientific Staffing & Functional Service Providers (FSP)

SECONDARYHLACAOAJ

Site & Investigator Platforms (Site Payments, Feasibility, Activation)

Healthcare & Life Sciences/Digital Health & Health IT/Clinical Trials & Research Informatics (eCOA/ePRO/EDC)

SECONDARYHLACAOAB

eCOA/ePRO/eDiary & Patient-Facing Data Collection

Healthcare & Life Sciences/Digital Health & Health IT/Clinical Trials & Research Informatics (eCOA/ePRO/EDC)

Keywords

• Paediatric translational research
• Research infrastructure services
• Orphan medical device development
• Paediatric drug discovery
• Clinical research network

Headquarters

HQ city

Leuven

HQ country

Belgium

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Research Infrastructure Services: EPTRI offers qualified basic, preclinical and translational research services covering paediatric medicines discovery and development to public and private stakeholders. Services are provided through its network of specialised research units across Europe and beyond. Revenue is generated through service provision to academia, industry, and healthcare organisations.
2. EU Funding and Grants: EPTRI receives EU funding through programmes such as EU4Health (e.g., OrphaDev4Kids project). The organisation also applies to ESFRI 2026 Roadmap for sustained European research infrastructure funding. Additional funding sources include participation in EU-funded research projects (ERDERA, c4c, EJP RD, EOSC).
3. Membership Fees: EPTRI operates with a membership model. The website includes a 'Become a Member' section and invites organisations to join EPTRI as Service Providers. Members include academic institutions, hospitals, patient organisations, and research centres across EU and non-EU countries.
4. OrphaDev4Kids Service Requests: The OrphaDev4Kids open call invites academics, individual researchers, startups, industrial players, and patient-led developers to request supporting services for new device development and adaptation of existing products for orphan and paediatric populations, funded under EU4Health Programme (2021–2027).

Go-to-market motion2 records

Distribution channels3 records

Marketing channels8 records

Core offering

EPTRI provides integrated, end-to-end translational research services across paediatric medicines discovery, development and clinical application through five Thematic Research Platforms (Medicines Discovery, Developmental Pharmacology, Biomarkers & Biosamples, Formulations, Advanced Therapy Medicinal Products) plus a Medical Devices platform. Its flagship OrphaDev4Kids initiative, funded under the EU4Health Programme, supports orphan and paediatric medical device development. Services are delivered to public and private stakeholders through a coordinated network of 100+ research centres across 25 EU and non-EU countries.

Product overview

European Paediatric Translational Research Infrastructure (EPTRI) is a pan-European research infrastructure providing integrated, end-to-end research services that bridge scientific discovery and real-world application for paediatric health solutions. The organization operates through five core Thematic Research Platforms (TRPs): Paediatric Medicines Discovery TRP, Developmental Pharmacology TRP, Paediatric Biomarkers and Biosamples TRP, Paediatric Medicines Formulations TRP, and Advanced Therapy Medicinal Products TRP, plus a dedicated Medical Devices TRP. These platforms are complemented by the OrphaDev4Kids initiative (EU4Health-funded project for orphan and paediatric medical devices), the EPTRI Educational Platform (offering webinars and toolkit), a Podcast Series, and connection to funding opportunities like the ERDERA Clinical Trial Call. EPTRI connects specialized research units across Europe to advance the paediatric research ecosystem.

Differentiator

Problem solved

Functional benefit

Products and services

• EPTRI Paediatric Research Services Integrated, end-to-end research services bridging scientific discovery and real-world application, offering qualified basic, preclinical and translational research services covering paediatric medicines discovery and development to public and private stakeholders.
• OrphaDev4Kids (Orphan and Paediatric Medical Devices Initiative) An EU4Health-funded project dedicated to supporting the development of orphan and paediatric medical devices, providing access to expertise, regulatory guidance, technical support and innovation services for academics, researchers, startups, industrial players, organisations, and patient-led developers.
• EPTRI Paediatric Medicines Discovery Thematic Research Platform Platform covering drug targets and assay methods for paediatric medicines, bioinformatics in paediatric drug design, and computational approaches to drug discovery, coordinated by Prof. Cosimo Altomare at the University of Bologna.
• EPTRI Developmental Pharmacology Thematic Research Platform Platform focused on pharmacokinetics, pharmacodynamics, dosing considerations in children, microdosing, dosage adjustment in neonates, and modelling and simulation approaches.
• EPTRI Paediatric Biomarkers and Biosamples Thematic Research Platform Platform covering identification, characterisation and validation of paediatric biomarkers, biosample collection, and paediatric biobanks.
• EPTRI Paediatric Medicines Formulations Thematic Research Platform Platform focused on paediatric formulation and preformulation, patient experience including taste improvement, and formulating delivery systems for biologics.
• EPTRI Advanced Therapy Medicinal Products Thematic Research Platform Platform dedicated to ATMP development infrastructure for paediatrics, covering gene and cell therapies, manufacturing challenges, scalability, and regulatory aspects.
• EPTRI Medical Devices Thematic Research Platform Platform covering design, development and integration of paediatric medical devices and emerging health technologies, including wearable devices and health technology designed with children.
• EPTRI Educational Platform Comprehensive educational resource offering webinars, the EPTRI Toolkit on Basic and Translational Paediatric Research, and training materials for patients, families, and researchers, including multiple webinar series covering topics from CONSORT/SPIRIT-Children guidelines to child health data and AI.
• EPTRI Toolkit on Basic and Translational Paediatric Research Educational toolkit on Basic and Translational Paediatric Research for Patients and Families.
• EPTRI Podcast Series A series of podcasts presenting EPTRI, its mission, and main research services to disseminate information about paediatric research infrastructure.
• ERDERA Clinical Trial Call Support Support programme connecting EPTRI community members to the ERDERA Clinical Trial Call allocating up to €30 million for sponsor-led Phase I, Phase I/II and Phase II clinical trials of medicinal products for rare diseases.

Quantifiable outcome

• OrphaDev4Kids project, funded under EU4Health Programme (2021–2027), provides services for development and adaptation of medical devices for orphan and paediatric populations
• +2 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature6 records

Partnerships

18 partnerships are on record, tiered core and secondary.

• i~HD (European Institute for Innovation through Health Data)coreStrategic or Co-development Partner · 26 May 2026i~HD co-hosts educational webinars with EPTRI on topics such as real-world health data for paediatric clinical research. i~HD brings expertise in Electronic Health Record R&D, EHR reuse for research, health data interoperability, and the European Health Data Space. Joint webinars feature speakers including Dipak Kalra (President of i~HD), Mats Sundgren (co-founder), and Peter Casteleyn.
• TEDDY NetworkcoreStrategic or Co-development PartnerTEDDY (European Network of Excellence for Paediatric Research) is a key EPTRI member network. EPTRI's board member Dr. Donato Bonifazi is also a Board Member at TEDDY. TEDDY's patient organisations (TEDDY Kids Network) collaborate with EPTRI on patient engagement initiatives including the OrphaDev4Kids project. TEDDY provides expertise in haemoglobinopathies, research methodologies, and operates patient expert groups (YPAG) across Europe.
• ERDERA (European Rare Diseases Research Alliance)coreStrategic or Co-development PartnerERDERA is a major EU initiative supporting multinational early-phase clinical trials in rare diseases. EPTRI collaborates with ERDERA by encouraging its community to explore ERDERA's Clinical Trial Call (allocating up to €30 million) and offers to support applicants by facilitating access to its multidisciplinary paediatric research expertise and helping identify relevant services and infrastructures.
• Enpr-EMA (European Network of Paediatric Research at EMA)coreStrategic or Co-development PartnerEPTRI participates in Enpr-EMA activities through its board member Dr. Donato Bonifazi who serves on the Enpr-EMA Coordinating Group. EPTRI presented at the Enpr-EMA 2025 Annual Open Meeting on translational research innovations and the importance of dedicated research infrastructures. EPTRI is also involved in Enpr-EMA working groups.
• EOSC (European Open Science Cloud)secondaryStrategic or Co-development PartnerEPTRI participates in EOSC initiatives through its members Dr. Rafal Bartczuk (Children's Memorial Health Institute, Warsaw) and Dr. Emidio Capriotti (University of Bologna) who serve on the EOSC Data Task Force. This Task Force focuses on interoperability, sharing, and reuse of health data among the European Health Data Space (EHDS), defining EOSC strategy for health data research.
• Children's Memorial Health Institute (CMHI), WarsawcoreStrategic or Co-development PartnerCMHI is a key EPTRI member institution in Poland and host of the EPTRI General Assembly and Scientific Meeting 2026 in Warsaw. Dr. Marek Migdal serves as Director of CMHI and as EPTRI Treasurer. CMHI represents EPTRI in the EOSC Data Task Force and contributes expertise in paediatric intensive care, clinical trials, and rare diseases.
• CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche)coreStrategic or Co-development PartnerCVBF is a non-profit research consortium based in Pavia, Italy, with 20 years of experience in health and pharmaceutical research. EPTRI Coordinator Dr. Donato Bonifazi is CEO of CVBF. CVBF hosts EPTRI's Central Management Office and provides expertise in European project management, clinical trials (DEEP project), and paediatric research networks.
• TRANSFORM AlliancecoreStrategic or Co-development PartnerEPTRI is a member of the TRANSFORM Alliance and actively contributed to the Position Paper on the EU Biotech Act I: Strengthening Europe's Framework for ATMPs. EPTRI particularly supported reflections related to paediatric research and advanced therapies, underlining the importance of ensuring children's needs are considered in the evolving European biotech and regulatory landscape. EPTRI board member Giovanni Migliaccio represents EPTRI in TRANSFORM Alliance.
• University of BolognacoreStrategic or Co-development PartnerThe University of Bologna is a key EPTRI member institution contributing to multiple Thematic Research Platforms. Prof. Cosimo Altomare (Full Professor of Medicinal Chemistry) coordinates the Paediatric Medicines Discovery TRP. The University hosts the EPTRI 2025 General Assembly in Bologna. Dr. Emidio Capriotti represents EPTRI in the EOSC Data Task Force.
• University of Bari 'Aldo Moro'coreStrategic or Co-development PartnerA key EPTRI member institution contributing to the Paediatric Medicines Discovery TRP (Prof. Cosimo Altomare) and Paediatric Medicines Formulations TRP (Prof. Nunzio Denora, Associate Professor of Pharmaceutical Technology). The university organized a webinar on paediatric formulations carrying biotech drugs and Covid-19 vaccines as part of European Biotech Week 2021.
• KU LeuvencoreStrategic or Co-development PartnerKU Leuven is the host institution of EPTRI's headquarters (AISBL registered office). Prof. Karel Allegaert (Professor at KU Leuven) serves as EPTRI President. KU Leuven contributes expertise in perinatal and developmental pharmacology and hosts the EPTRI 2026 General Assembly meeting venue.
• EATRIS (European Translational Medicine Research Infrastructure)secondaryStrategic or Co-development PartnerEATRIS is a European research infrastructure for translational medicine. Giovanni Migliaccio serves as Senior Advisor for EATRIS while also serving as Scientific Director of CVBF and EPTRI contributor. EPTRI works complementarily with EATRIS to advance translational research.
• iCAN (International Children's Advisory Network)secondaryStrategic or Co-development PartneriCAN fosters greater global understanding about the importance of the paediatric patient and caregiver voice in healthcare, clinical trials, and research. EPTRI Board Member Dr. Donato Bonifazi serves on the iCAN Advisory Group. Leanne West (Georgia Tech) serves as President of iCAN and has participated in EPTRI scientific meetings.
• Gianni Benzi Pharmacological Research FoundationcoreStrategic or Co-development PartnerThe Gianni Benzi Foundation organises the XVII Foresight Training Course supported by EPTRI. It coordinates research activities within EPTRI including ethics and regulatory services, HTA services, and biostatistics. Lucia Ruggieri represents EPTRI Central Management Office. The foundation has expertise in haemoglobinopathies and international research coordination.
• c4c (conect4children)secondaryStrategic or Co-development Partnerc4c is a pan-European clinical trial network for children. EPTRI contributed to c4c project activities. Dr. Marek Migdal served as European coordinator of c4c. Fedele Bonifazi serves as a member of the c4c Steering Committee. EPTRI continues to collaborate with c4c on paediatric clinical trial initiatives.
• EJC RD (European Joint Programme on Rare Diseases)secondaryStrategic or Co-development PartnerEJP RD is an EU-funded programme on rare diseases. EPTRI is involved in EJP RD activities. Dr. Donato Bonifazi has been involved in EJP RD as part of EPTRI's engagement in rare disease research networks across Europe.
• Duchenne Data FoundationsecondaryStrategic or Co-development PartnerOne of EPTRI's new members as announced in July 2025. The Duchenne Data Foundation is a patient organisation focused on Duchenne muscular dystrophy research, representing EPTRI's expansion of membership to include disease-specific patient advocacy groups.
• European Medicines Agency (EMA)coreStrategic or Co-development PartnerEPTRI engages with EMA through Enpr-EMA, the European Network of Paediatric Research at EMA. Dr. Donato Bonifazi serves on the Enpr-EMA Coordinating Group. EPTRI is a member of the ACT EU multi-stakeholder platform Advisory Group. Viviana Giannuzzi represents patient organisations on the EMA Paediatric Committee. EPTRI has participated in EMA public consultations on ATMP clinical trials guidelines.

Scale indicators5 records

Recent moves7 records

Expansion highlights4 records

Direct peers

• EATRIS (European Advanced Translational Research Infrastructure): Pan-European translational medicine research infrastructure covering drug discovery to clinical proof-of-concept. Most directly comparable to EPTRI as a fellow ESFRI-aligned translational research infrastructure; EPTRI board member Giovanni Migliaccio is also a Senior Advisor at EATRIS.
• TEDDY Network: European Network of Excellence for Paediatric Research focused on clinical trials methodology and patient engagement. Direct peer in paediatric research; EPTRI's coordinator sits on the TEDDY Board, and TEDDY Kids Network collaborates with EPTRI's OrphaDev4Kids.
• ERDERA (European Rare Diseases Research Alliance): Major EU initiative supporting multinational early-phase clinical trials in rare diseases with up to €30M in trial funding. Directly comparable as a paediatric-relevant rare-disease research alliance; EPTRI is an active collaborator supporting applicants.
• Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency): EMA-coordinated network of paediatric research networks, organisations, and investigators. Direct peer for paediatric research coordination and regulatory engagement; EPTRI participates through Enpr-EMA Coordinating Group membership.
• ELIXIR: Intergovernmental life-science data infrastructure managing bioinformatics resources across Europe. Comparable as an ESFRI research infrastructure, with overlapping interest via EOSC and health-data interoperability; EPTRI members participate in the EOSC Data Task Force.
• Euro-BioImaging: European research infrastructure providing open access to biological and biomedical imaging technologies. Comparable as an ESFRI infrastructure and potential complement for paediatric biomarker and ATMP imaging needs.
• ECRIN: European Clinical Research Infrastructure Network coordinating multinational clinical trials across Europe. Comparable as an ESFRI infrastructure supporting clinical research operations; potential collaborator or substitute for sponsors building paediatric programmes.
• BBMRI-ERIC: European biobanking research infrastructure managing one of the world's largest sample collections. Comparable as an ESFRI research infrastructure; EPTRI's Paediatric Biomarkers & Biosamples TRP overlaps directly with BBMRI-ERIC's biobanking mandate.
• conect4children (c4c): Pan-European paediatric clinical-trial network and IMI-funded initiative. Highly comparable to EPTRI on paediatric clinical-trial coordination; EPTRI has been an active collaborator with c4c Steering Committee members.

Broad incumbents

• EUCROF (European Contract Research Organisations Federation): Federation representing European CROs and service providers. Comparable as a broader industry association for clinical research service providers; EPTRI's coordinator Donato Bonifazi chairs the EUCROF Events & Training Working Group.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/eptri_aisbl
• YouTubeyoutube.com/channel/UCwm6GfVQgo57kkVgn6L47-A
• Facebookfacebook.com/EPTRI
• LinkedInlinkedin.com/company/eptri

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about European Paediatric Translational Research Infrastructure