Using OMOP and Other Real World Data Standards to Support Regulatory Submissions
Project Description |
This project aims to raise awareness of data standards for real-world data (RWD) to support regulatory use, with a focus on commonly used data sources such as electronic health records, claims data, patient-reported outcomes, and other observational datasets. It will evaluate common data models (CDMs), including OMOP and the OHDSI ecosystem, alongside alternatives such as PCORnet, Sentinel and CDISC standards. Differences in regulatory guidance and preferred standards across global agencies can lead to inefficiencies, as data may need to be transformed multiple times to meet varying requirements. OMOP, endorsed by the EMA and supported by a mature community, provides a strong reference point for comparison. The project will deliver a white paper assessing the strengths, limitations and maturity of key data standards, their suitability for different data types and use cases, and the supporting communities and tools. It aims to promote greater alignment, improve data quality and interoperability, and initiate industry dialogue on the use of these standards for regulatory submissions. |
Project Leads | |
|---|---|
Alexa Parliyan, Pfizer | |
Berber Snoeijer, ClinLine | |
Birol Emir, Pfizer | |
Sanket Kalyankar, Sumptuous Ds | |
Nicola Newton, PHUSE Project Coordinator |
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