Now, with both the FDA and the EMA showing support for eSource, it’s time for drug sponsors and CROs to begin to change the existing industry paradigm in order to implement these advancements and improve the way clinical research is conducted.
TORONTO (PRWEB) November 04, 2019
Join Ed Seguine, CEO at Clinical Ink and Jonathan Andrus, Chief Business Officer at Clinical Ink in a live webinar on Tuesday, November 19, 2019 at 10am EST (3pm GMT/UK) to hear about the implications behind the EMA’s qualification opinion and the benefits of using eSource solutions in clinical trial conduct.
In late September, the EMA released an important qualification opinion in favor of using eSource direct data capture (DDC) in clinical trials. Although the FDA had expressed support for clinical eSource solutions, the EMA had previously been cautious. The EMA’s opinion identifies many areas where eSource DDC captures source data more efficiently than traditional electronic data capture. It provides answers to a number of regulatory eSource questions and presents recommendations for implementing eSource DDC for use in clinical trials. The opinion also serves to eliminate the prior discrepancy in recommendations between the EMA and FDA.
The opinion concludes that eSource DDC, when implemented correctly, is Good Clinical Practice-compliant and can be used in support of regulatory filings. The metrics supporting the request indicated that the time to study data availability dropped six-fold due to its use of eSource DDC. Furthermore, the number of data points that remained unchanged throughout the studies increased by 7 percent, which indicates fewer changes due to data queries or monitoring. What’s more, the time to resolve data queries dropped by more than half.
Despite growing evidence to support the use of eSource solutions for clinical trials, industry acceptance has been slow — mostly due to outdated process models. The EMA’s opinion should help to increase the adoption of these electronic data capture technologies industry-wide. Now, with both the FDA and the EMA showing support for eSource, it’s time for drug sponsors and CROs to begin to change the existing industry paradigm in order to implement these advancements and improve the way clinical research is conducted. Register for this free webinar to learn more.
For more information or to register for this event, visit The Future Is Now: EMA Qualification Favors Clinical Trial eSource Solutions Over Outdated Processes.
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