Studyfyr: A Platform for Governance and Reproducibility in Clinical Research using FHIR/OMOP
Studyfyr - Pontegra Software Technologies
Summary
Studyfyr provides a platform to govern and manage clinical research execution environments based on standards like FHIR and OMOP. This ensures reproducible data pipelines, managed audit trails, and secure publication of results.
Details
This article introduces Studyfyr, an operational model for clinical research focusing on governance and reproducibility. The platform uses standard data formats such as FHIR and OMOP and supports large-scale distributed processing via Apache Spark. Users can build notebook-friendly pipelines using the Clinical Research Toolkit (CRT), connecting to FHIR sources (server or lakehouse) for querying. Key features include safe anonymization/pseudonymization of data, and an audit trail design that records only metadata. Furthermore, output review and publication processes are controlled, making it suitable for research in highly regulated environments. The solution is ideal for secondary-use research requiring high governance, such as hospitals, academic TREs, and life sciences companies.
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