Using OMOP and Other Real World Data Standards to Support Regulatory Submissions

Using OMOP and Other Real World Data Standards to Support Regulatory Submissions

Project Scope 

The scope of the project includes developing awareness of data standards specific to real-world data to support regulatory purposes. Common data models (CDMs) and taxonomies that are specific to the most used real-world data sources by industry, member companies and regulatory bodies across the globe will be in scope, such as electronic health record sources, patient reported outcomes, widely accepted claims data sources, and other commonly used observational data. OMOP and the OHDSI community will be the focus and will be evaluated against other CDMs and standards (such as PCORnet, Sentinel and CDISC).

Project Leads

Email

Project Leads

Email

Alexa Parliyan, Pfizer

Alexa.Parliyan@pfizer.com

Berber Snoeijer, ClinLine

b.snoeijer@clinline.eu

Birol Emir, Pfizer

Birol.Emir@pfizer.com

Sanket Kalyankar, Sumptuous Ds

sanket.kalyankar@sumptuousds.onmicrosoft.com

Nicola Newton, PHUSE Project Coordinator 

nicky@phuse.global 

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