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Elligo Receives FDA Award to Evaluate Harmonised Data Model

A leading clinical research infrastructure provider, Elligo Health Research, is now all set to evaluate a harmonized data model the FDA built so that real-world data collected from different sources could talk to each other.

While the U.S. Food and Drug Administration has already approved various cancer immunotherapies, the agency seeks to better understand their safety in a real-world setting. However, there are multiple ways to collect and represent data, and there is a lack of interoperability — the capability for systems to exchange and aggregate data from various sources. This leads to an inability to combine and analyze data, thus severely limiting its usefulness.

A data architecture and process that enable meaningful data exchange will allow us to leverage real-world evidence and patient experiences to accelerate learning,” said Rebecca Kush, PhD, Elligo’s scientific innovation officer. “Competing data models should not impede access to important information. We commend the FDA for spearheading this project.

Funded through the Patient-Centered Outcomes Research Trust Fund available under the Affordable Care Act, the project has developed a common data architecture dubbed the BRIDG that allows data to be exchanged between models.

The BRIDG will serve as the overarching harmonizer or intermediary to allow the data to be converted to a single format such that they can be aggregated into one database,

” explained Kush.

Elligo will evaluate potential data sources to ensure that they can provide safety data and other relevant clinical data in one of the predesignated models and oversee the use case activities, and the FDA will examine the data for safety profile analyses, Kush told FierceCRO. “Through this project, Elligo will learn more about using EHRs as potential eSource data sources for research,” she said.

While the promise of real-world data for research is great, the ultimate value comes from being able to rapidly share high-quality data from electronic health records,” said Chad Moore, Elligo president. “We’re honored to be part of this project.

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