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EMA Pursues Common Data Model for Europe
October 16, 2018
The European Medicines Agency wants to develop a common data model (CDM) to help speed Europe’s drug development and it’s looking for a hybrid because no current system can answer all the questions posed by the product life cycle.
The agency believes the CDM should mirror the compliance checks in the FDA’s Sentinel system but it’s also considering the Observational Medical Outcomes Partnership (OMOP) CDM supported by a global collaborative network of researchers, according to a new report.
“Each CDM system represents a trade off on where to set the balance between the efforts invested in data management and data analysis. Where the emphasis is placed is likely to have an impact on the speed of studies,” the EMA said.
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