Eliminating the Burden of FDA Form 1572

October 15, 2020

2 minute read

For investigators running a clinical trial on a new drug or agent, FDA Form 1572 is all too familiar. This mandated form ensures compliance to the FDA Code of Federal Regulations. It seems innocent enough, but the thought of completing this form and the associated summary reports is enough to make any clinical trial lead bristle.

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While the simple FDA Form 1572 appears to be a helpful way to document a clinical trial, many organizations find it time-consuming and frustrating to complete.  

FDA Form 1572 (1)

Manually searching for data and combining information from hundreds of FDA 1572 forms across multiple sites and spans of time isn’t for the faint of heart. Clinical trial leads spend a significant amount of time—often hundreds of hours—on this single task.

Organizations are tired of losing productivity to this menial manual task, and clinical trial leads are sick of being asked to pore over hundreds of forms. Time-strapped life sciences and pharmaceutical companies demand an easier, automated solution that doesn’t extend timelines and burn through valuable resources.

Are these challenges wasting your company’s time and resources? Read the whitepaper to learn how technology is being used to automate the manual make-work associated with FDA Form 1572.


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