Navigating Electronic Data Submission Guidances
Terek Peterson, Senior Director of Global Statistical Standards, Chiltern
Dave Izard, Senior Director of Clinical Data Standards, Chiltern
In this episode, we hear from two experts on the FDA’s regulations regarding electronic submissions. They cover issues such as what has changed over the last 3 years, the latest FDA guidance documents, reasons for complying, and deploying standards when clinical development efforts are initialized.
This podcast also has a related white paper which covers additional information on this topic and can be downloaded from the link below.