Navigating Electronic Data Submission Guidances

Publish Date:
March 9, 2017
Authors:
David C. Izard, Senior Director, Clinical Data Standards & Terek J. Peterson, MBA, Senior Director, Global Statistical Standards

In this podcast, we’ll discuss the guidances compelling organizations to compile data into standardized, digital datasets, the FDA’s motivation behind these changes and the benefits to — as well as the hopes of — the organizations that must submit standardized data.

There is also a related white paper on this topic, which you can download here.

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