Advantages of EDC vs. Paper in Clinical Trials: Oracle Clinical RDC by CRO Consultant Kammy Ghuman

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Industry experts estimated that 60% of all new trials (Phase I – III) implemented Electronic Data Capture (EDC) in 2008. These figures are expected to increase in 2009. The largest growth is anticipated for Phase I and II trials. Why are more companies transitioning to EDC instead of Paper to collect data during a clinical trial?

Electronic Data Capture (EDC) allows data to be entered by the clinical site directly into a Clinical Data Management System (CDMS) such as Oracle Clinical RDC (Remote Data Capture). Data Management is achieved in real time, with instant edit checks/validation procedures firing as sites are entering data into the EDC. Instant query resolution reduces both query response time and hence overall time to achieve clean data. The usual cycle time that is required for a paper study is reduced since there are no CRF´s to be cycled between data entry and data management personnel. Prior to EDC usage, Data Management personnel would prepare paper queries to send to the sites. Sites would then provide written clarifications to send back to the sponsor for update in the database. This process would be repeated multiple times until all of the data was validated. Intuitively, validation in real time using an EDC system such as Oracle Clinical saves time and money.

The real-time data validation afforded by an EDC system imparts other advantages as well. Study data is fresher in minds of site coordinators when queries are presented to them. Coding of Adverse Events, Concomitant Medications, or Protocol Deviations can be done as the data is entered. With paper studies, only after the data is entered and the discrepancies are resolved can any coding take place. Also, data collected outside of the CDMS can be integrated with the EDC system in real time. Another major benefit of EDC is that it allows companies to see trends and assess risk much earlier in a clinical trial potentially allowing correction or revision of problematic clinical trials and prevention of additional costly trials. In addition, using EDC allows rapid database lock since last minute issues can be quickly resolved, resulting in faster FDA submissions and subsequent approval. Moreover, with all of the challenges facing our environment, using an EDC system is a major step towards helping the industry to "go green," as it saves tremendously on the paper that is used, transported, printed, and stored for a clinical trial.

A CRO such as Innoventz can supply a hosted EDC platform for companies running clinical trials and help with many of the implementation issues encountered by companies new to EDC. Innoventz is a provider of Oracle Clinical RDC for electronic data capture and associated data management services. Oracle Clinical RDC has proven stability, with over 6000 sites using RDC version 4.5.3. With the upgrade to version 4.5.3, RDC is much easier to use than previous versions, giving the user the look and feel of paper while taking advantage of the most cutting edge EDC functionality.

For more information on the benefits of EDC and what Oracle Clinical can provide for you clinical trial, please visit us at www.innoventz.com or email us at info@innoventz.com