A therapy in the Belgian reimbursement process needed Belgian real-world evidence on how patients with interstitial lung disease are actually managed, and how the disease progresses in routine care.
The sponsor had trial data and no national real-world picture, because the data sits in separate hospitals, in separate systems, under separate data governance regimes. Building that picture is not something a sponsor can do alone.
We coordinate the whole study: contracting with the sponsor, contracting with each expert center, building the data dictionary and extraction specification from the required report tables, and preparing the methodology documentation each hospital's data access committee needs.
Six Belgian interstitial lung disease expert centers take part — UZ Leuven, ZAS Antwerp, HUB Erasme, UCL Saint-Luc, CHU Liège and UZ Gent.
Each hospital extracts in its own format and transfers coded, pseudonymized patient-level data. Processing runs in a trusted third party environment, and the sponsor receives aggregated, anonymized output only. Source data, hospital data and personal data never reach the sponsor.
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