Federated real-world data registry with a KOL steering committee

The set-up

A multi-stakeholder disease registry combining hospital record data with data patients provide directly through an app. Each hospital keeps control of its own data, and compliant merging runs through a Trusted Third Party designed around European Health Data Space and GDPR expectations.

A steering committee of clinical leaders governs the science. Ethics approval is obtained per protocol. The registry starts with a retrospective merge in year one and grows prospectively from there.

What the sponsor gets

Proprietary longitudinal cohorts that serve medical, market access and commercial teams from one dataset, rather than three separate exercises.

A flagship example

One registry running with more than 1,000 patients across 10 EU countries, with three global pharmaceutical companies co-sponsoring at the same scientific table, and seven peer-reviewed publications and congress abstracts to date.

What every project includes

An ePRO patient app, a sponsor dashboard covering per-site inclusions and adherence with CRM integration, eConsent, the Trusted Third Party privacy framework, hospital EHR integration, and KOL steering with a publication pipeline.