Saving Time and Money with Submission Ready SDTM Datasets

Solution | elluminate®

Clinical data is not only driven by complex protocols and medicine, but it also stems from multiple sources (Labs, EDC, CTMS, wearables, among others). Agios needed a way to collect, compare, and extract meaning from their clinical data, and turned to the elluminate® Clinical Data Platform.

Challenge

Agios required a system that would streamline and centralize data acquisition, one that would allow them not only to intake, but to output data for review and analysis. They also wanted a platform that possessed the ability to map that data in a standard structure, SDTM, and enabled the review of data-sets with user friendly visualization. Their ultimate goal was to implement a data hub that would allow them to analyze their data in-house, saving both time and money.

Solution

elluminate can ingest data from multiple sources and in almost any format. While the platform retains the data in its original format, it also enables standardization of that data into a powerful relational database engine and groups it into userdefined staging areas. Agios not only made use of elluminate’s data repository capabilities, but also elluminate’s Mapper application. Mapper employs an intuitive drag and drop interface that allows users to produce customized data sets as well as map those sets to SDTM. Once uploaded, both raw and mapped data sets are available for visualization, enabling users to easily review and analyze their data.

Results

By implementing data loading, reporting, mapping, and extraction through elluminate, Agios was able to simplify its data flow. As part of the implementation, Agios validated elluminate’s data loading module, including importing data from its Medidata Rave URL and from individual vendors (through the use of Aspera).

Agios is in the process of expanding their use of elluminate, including rolling out the Clinical Analytics product for use by Clinical Operations. elluminate Data Central is also being considered.

“I can say with complete confidence that elluminate has been proven to generate fully compliant SDTM datasets.”

– Bob O’Connor, Associate Director, Clinical Data Systems, Agios Pharmaceuticals

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