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Case Study

Data on trial

INTIENT Clinical helps global biopharmaceutical company get life-saving drugs through clinical trial processes more efficiently.

Call for change

Proof of concept that challenged efficiency. The positive results of improving clinical data management in an expanding pipeline of drugs.

When tech meets human ingenuity

The study data tabulation model (SDTM) engine, powered by INTIENT Clinical, converted raw clinical trial data into a standardized format that regulatory authorities like the US Food and Drug Administration (FDA) can review consistently.

Consolidation of data

INTIENT Clinical consolidated internal and external clinical trial data sources into a single data management and warehousing platform.

FDA-required format

INTIENT Clinical automated the output of clinical trial databases and puts them into the US FDA-required format.

50%

Automated processes and a 50% decrease in trial data conversion efforts mean patients get access to life-saving medicines sooner than previously possible to help improve patient outcomes.

90%

The proof of concept successfully performed SDTM conversion, showing that up to 90% of the SDTM processes could be automated and the conversion process effort halved.

100%

The proof of concept showed excellent results. In both cases, it detected data anomalies early to make all SDTM conversions correct and compliant first-time, a 100% increase.

A valuable difference

The SDTM conversion pooled the company’s data from its clinical data collection tool, as well as sources from three external vendors.
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