Both EU-PEARL and openMedicine center on secure, compliant handling of sensitive patient data across multi-institutional settings.
CUSTODIX NV
Belgian health informatics SME specialising in privacy-preserving data governance and platform infrastructure for multi-site clinical research.
Their core work
Custodix NV is a Belgian health informatics SME that builds and operates platforms for privacy-preserving analysis of clinical and patient data. Their core work involves enabling secure, pseudonymized access to sensitive health records across multiple sites — allowing researchers to run studies without centralizing raw patient data. In EU-PEARL, they contributed data governance infrastructure and platform operations for a large adaptive multi-disease clinical trial covering conditions ranging from tuberculosis to neurofibromatosis. In openMedicine, they applied their health data interoperability expertise to improve access to medicine-related information across healthcare systems.
What they specialise in
EU-PEARL (2019–2023) explicitly involved platform trial operations for adaptive multi-disease trials including major depressive disorder, tuberculosis, NASH, and neurofibromatosis.
EU-PEARL keywords include Bayesian statistics alongside platform trial operations, indicating Custodix contributed to or supported adaptive design data infrastructure.
openMedicine (2015–2016) focused on interoperability and open access to medicine data across European healthcare systems.
How they've shifted over time
In their first H2020 project (openMedicine, 2015–2016), Custodix worked at the level of health data infrastructure and open access to pharmaceutical information — an interoperability-first approach with no preserved keywords suggesting a broad, exploratory scope. By their second project (EU-PEARL, 2019–2023), the focus had sharpened considerably toward clinical trial data governance, patient-centredness, and the operational complexity of running adaptive platform trials across multiple disease areas simultaneously. The shift signals a maturation from general health data plumbing toward specialized, compliance-heavy clinical research infrastructure.
Custodix is moving deeper into regulated clinical research infrastructure — specifically the data governance and operational layer of complex adaptive trials — which positions them well for future projects in decentralized or platform clinical trials.
How they like to work
Custodix has participated in both their H2020 projects as a non-coordinating partner, suggesting they prefer to contribute specialist capabilities within larger consortia rather than drive projects themselves. Despite only two projects, they accumulated 48 unique partners across 17 countries, which indicates participation in large, multi-stakeholder initiatives rather than tight bilateral collaborations. This profile suggests they are reliable specialist contributors who integrate well into complex consortia without requiring a leadership mandate.
Custodix has built a notably wide network for an SME with only two projects — 48 unique partners spanning 17 countries, almost certainly driven by EU-PEARL's large pan-European consortium structure. Their connections likely include academic medical centers, clinical research organizations, and patient advocacy groups across Western and Central Europe.
What sets them apart
Custodix occupies a specific and hard-to-replicate niche: a small, agile company that understands both the technical and regulatory dimensions of health data — pseudonymization, federated access, GDPR compliance in clinical research — without the overhead of a large IT consultancy. For consortium builders, they fill the data governance gap that academic partners rarely cover and that large tech vendors often overbuild. Their direct experience with patient-centric, multi-disease adaptive trial platforms (EU-PEARL) is a concrete differentiator in a space where most participants bring only disease-area or statistical expertise.
Highlights from their portfolio
- EU-PEARLA large-scale RIA running from 2019 to 2023 covering four distinct disease areas under a single adaptive platform trial framework — one of the most complex clinical data governance challenges in EU health research.
- openMedicineCustodix's earliest H2020 involvement, focused on open access to medicine data — the highest-funded of their two projects at EUR 299,625 and likely the foundation of their health data interoperability credentials.