The Benefits of EDC Realized - Applied Clinical Trials

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The Benefits of EDC Realized


Applied Clinical Trials


Pivotal additions

A key to PPD's use of Oracle's RDC Onsite is that electronic case report forms (eCRFs) can be set up to look and feel like paper CRFs.

The new version includes features key to investigator sites. CRAs like special page views for recording adverse events in addition to key log pages and the ability to work on multiple eCRF pages.

The change to the discrepancy management system provided a new eCRF integrated discrepancy feature, allowing investigator sites and CRAs side-by-side review of data and discrepancies, thus saving time.

Pleasing results

At PPD headquarters, the upgrade to OC RDC Onsite 4.5.3 was consistent with its overall strategy to make investigator sites successful with their clinical trial data acquisition and reporting by providing rapid data collection with an application that is intuitive and easy to use. This product also allowed PPD teams and its sponsors to integrate with other data sources (e.g., IVR and central labs) and provide needed reports for rapid review of progress and on-time reviews for safety and other business decisions.

For the CRO, the results were equally satisfying. If time is money, which it is, then success speaks for itself. Using the new OC RDC Onsite system, PPD has been able to have data cleaned in real time for optimal interim trial decisions and to have it fully finalized within 10 days after the last subject visit.

"Our sponsors and investigators have been very pleased with our approach and tools," said Streeter. The benefits of technology...realized.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials, email:


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