Business Challenge
Setting up data repository for analysis of clinical trials.
A leading client in the pharmaceutical companies space with a growing pipeline wanted to set up a data repository to analyze data across clinical trials.
Situation: Limited visibility into clinical trials
The client in the pharmaceutical companies space had legacy and on-going clinical trials data in different formats and systems. They had limited ability to visualize and analyze data across trials, and inability to aggregate and standardize data for analysis and submission.
Solution
Standardization of all clinical data using CDISC SDTM and CDASH standards.
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We worked with the client to determine their goals and requirements, and setup clinical data repository. We aggregated and standardized all of their clinical data using CDISC SDTM and CDASH standards and mapped their legacy data leveraging next generation ETL capabilities. We developed programs and derivations to convert, integrate, and standardize their data into the platform.
Impact
Better access to multi-dimensional data for decision-making.
The client in the pharmaceutical companies space was able to access and perform analysis and on multi-dimensional clinical data views by role (i.e., safety analysts, data managers, medical monitors, biostatisticians, and clinical trial managers). Our solution also helped the client implement data standards based on CDISC’s SDTM for all legacy, on-going, and future trial data to expedite data analysis and submission.
