Lessons Learned from Implementing an Enterprise Clinical Data Hub

Agios Pharmaceuticals chose elluminate® to bring together all their data and are using it to create submission ready SDTM datasets to save time and money.

1000+ x

Archived Studies

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500+

Ongoing Studies

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50

Difference Data Sources

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Challenge

Agios required a system to centralize data acquisition and enable output of data for review and analysis. They wanted a platform that would provide the ability to map data in SDTM and facilitate the review of data-sets with user friendly visualization.

Solution

elluminate can ingest data from multiple sources and in almost any format. It also enables standardization of that data into a powerful relational database engine. Agios not only made use of elluminate’s data repository capabilities, but also elluminate’s Mapper application.

Results

By implementing data loading, reporting, mapping, and extraction through elluminate, Agios was able to simplify its data flow. To date, Agios has completed SDTM mapping for numerous studies and have achieved excellent Pinnacle 21 scores.

Business Challenges

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. 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

Agios employed a cross-functional team of members from IT, clinical operations, safety, data management, and biostats. To evaluate the various providers, they created a list of testing criteria that they used like a report card. While the cross-functional team tested the product, a quality team audited the vendor for proper practices. The first product that Agios piloted took the team four months to fully test. “We learned a lot from that process” said O’Connor. Though the functionality of the product was adequate, the team agreed that it needed a few enhancements and, overall, the product wasn’t as user friendly as they wanted it to be. Luckily, the company had better luck piloting a second clinical data hub: elluminate®.
For its second pilot product, Agios used eClinical Solutions’ cloud-based Clinical Data Hub elluminate. The elluminate platform allows for end-to-end data management by not only enabling the import of clinical trial data, but by also allowing users to map, visualize, and export that data for submission. 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 user-defined 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.

Key Practices and Lessons Learned

a) Establish Testing Criteria 

Know what qualities you wish to evaluate in a product, “especially if you don’t know what kind of functionality is available in the market,” said O’Connor. Having the criteria and the score card made the ultimate selection of elluminate’s Clinical Data Hub easy. 

b) Involve QA

Make sure Quality Assurance is engaged early in the process. “Involving QA in the selection process enabled us to perform our evaluation of elluminate faster,” said O’Connor, speaking about Agios’ pilot program.

c) Check Resources

 “Make sure you have appropriate resources lined up for when you’re doing your testing,” O’Connor advises. Agios had multiple GXP systems going live for other projects, and the Data Systems group was competing for necessary resources.

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). To date, Agios has completed SDTM mapping for numerous studies. “We achieved excellent Pinnacle 21 scores as well, demonstrating elluminate’s ability to produce compliant, submission-worthy SDTM data sets,” said O’Connor.

Moving forward with elluminate

Agios is in the process of expanding their use of elluminate, including rolling out the Clinical Trial Operations Analytics product for use by Clinical Operations. elluminate Data Central is also being considered. “We see Data Central as something that could play a central role in our data review process… That’s something we’re very excited about.”

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