Mid Size Pharma Implements elluminate® for Standardization and Analysis Needs

posted on January 15th 2015 in Case Studies with 0 Comments /

A mid-size pharmaceutical company with a growing pipeline had both legacy and ongoing clinical trials data in disparate formats and systems. In the current state, the data was of limited use without significant programming efforts. Additionally, even after traditional programming, their ability to analyze and visualize the data across trials was limited as the data wasn’t aggregated or standardized.

Additionally, multiple functional groups such as biostatistics, clinical operations, and clinical data management were interested in interacting with their clinical data for different uses that required unique views. Although the organization standardized their electronic data capture system, the use of multiple data management partners (including internal resources) resulted in their clinical data being in disparate structures and formats.

Our client set out to find a partner and product that would be able to integrate their legacy data, ongoing clinical trial data, and data from their CTMS system, and aggregate their data in the most cost-effective way leveraging industry standards such as CDISC’s SDTM. After centralization, they wanted to utilize integrated visualization and analytics capabilities to gain insights via specific views of data for a trial as well as across trials.

Our Solution
eClinical Solutions worked with the client to determine their goals and requirements, and after, proposed and implemented our Clinical Data Repository, elluminate®, which was built specifically to meet those objectives. Our team aggregated and standardized all of their clinical data using CDISC SDTM and CDASH standards and converted their legacy data leveraging next generation ETL capabilities. We developed programs and derivations to convert, integrate, and standardize their data into the elluminate® platform. Utilizing web services, the client’s ongoing clinical data was integrated into the elluminate® platform near “real time”, in the defined standard, and at a schedule as needed.

Our team worked with the client’s various functional groups to identify their data visualization needs and implemented custom dashboards. In addition, we trained client users on the integrated ad-hoc reporting and business intelligence software allowing them to build views of their data through the development of reports, graphs, and patient profiles. Through the reports and dashboards, the client was able to perform analysis and access multi-dimensional clinical data views by role (ie, data managers, safety analysts, biostatisticians, medical monitors, and clinical trial managers).


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