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Streamline Data Collection in Clinical Trials

Optum® True Source™ Direct Data Capture helps improve regulatory-grade data collection accuracy and ease trial site burden.


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.

Transform data into a study-specific clinical trial database

By conducting a study through the Optum® Digital Research Network, access a network of True Source-enabled sites to access more benefits.


Reduce burden of manual data entry

Help save time and money by eliminating data entry duplication, transcription errors and training time to work with a custom system.


Increase trial participation opportunities

Enable pragmatic study designs with more types of sites thanks to a reduced need for study data collection infrastructure.


Respond more quickly to protocol concerns

Uncover insights faster by monitoring and analyzing trial data in real time.


Automatically produce regulatory-grade data

Deliver quality data with an audit trail, mapped directly into the electronic data collection system without the manual intermediary steps.

Case study

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.

If I were to estimate time saved [in data collection and the query process], I would say it’s an 80% reduction in what we would usually do.**

Clinical Trial Manager and RN, Reliant Medical Group

Peggy Preusse

Improve trial data collection quality and help ease site burden

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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