Help improve data collection accuracy and ease trial site burden
Up to a quarter of a typical trial budget can be spent on manual source data verification (SDV)* using processes that are inefficient and error prone. Time and dollars are spent solving for custom systems, the capture of hundreds of key data points, and disjointed integration with electronic health record (EHR) data.
The U.S. Food and Drug Administration supports finding a more efficient process to move EHR data into the electronic data capture (EDC) system for a clinical trial.
To streamline data collection in clinical trials, Optum uses True Source Direct Data Capture. The process transforms EHR data directly into a trial-specific database such as an electronic data capture system. It also includes a full audit trail to generate a regulatory-grade, real-world data set.
Study shows decreased time spent on clinical data collection
Optum demonstrated successful EHR to EDC mapping in an observational trial, reducing site staff labor while ensuring EDC data accuracy.
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*Andersen JR, Byrjalsen I, Bihlet A et al. Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials. Br J Clin Pharmacol. April 2015.
**Optum case study: Using electronic health records and time-saving technologies to modernize clinical trials