Agios Produces Compliant & Submission-Worthy SDTM
Right-Sizing Clinical Trial Management Systems for the New Age of Clinical Development
Agios Produces Compliant & Submission-Worthy SDTM with 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.
Related products
Needing a way to collect, compare, and extract meaning from their clinical data, Agios leveraged elluminate Analytics, Mapper, and CTMS Insights. By implementing data loading, reporting, mapping, and extraction through elluminate, Agios was able to simplify its data flow.
Mapper
Powerful data transformation, unification and automation from diverse data sources and formats without programming for submission and analytic needs.
Clinical Analytics
Comprehensive visualizations and reporting that support safety and efficacy decisions within and across trials, operational analytics that help proactively manage your trial.
Clinical Trial Management System (CTMS) Insights
Manages and combines all your operational data into one source of truth that you can benefit from for both your ongoing and future trials.
Related services
As part of the implementation, Agios validated elluminate’s data loading module, including importing data from its Medidata Rave URL and from individual vendors. With the aid of Data Conversation and Standardization services, Agios achieved their goal of being able to analyze their data in-house, saving both time and money.
Data Conversion and Standardization
Tech-enabled approach to shorten submission timelines and improved ability to support real-time creation of “submission ready” datasets
elluminate Implementation
Customized implementation services are based on your organizational data strategy and needs to ensure business transformation and ROI
“
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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