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jq1234

12/14/19 2:45 PM

#227706 RE: DewDiligence #227704

Validated and accepted software for all statistical related work for submission purpose is SAS, pretty much used by industry across the board. For standard submission data visualization etc, there are many choices, FDA chose one - not sure if I should say what it is or not - but I don’t know if it is subject to change and how often it is subject to change. One can license from the company who developed it to use it - used to be a small company but acquired by large one - but very expensive even for a not so small company, many try to use alternatives these days.
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jq1234

12/14/19 9:56 PM

#227714 RE: DewDiligence #227704

I found a presentation that is public with quite full review of FDA data submission process and FDA data warehouse system, plus tools and softwares for data visualization and report generating etc, including companies who developed those tools.


http://portal.cdisc.org/CDISC%20User%20Networks/Europe/English%20Language/Presentations/2010%2009%2030%20-%20TC%20-%20Traceability%20btw%20SDTM%20and%20AdaM%20;%20CDISC%20Data%20Standards%20Validation/CDISC%20Data%20Standards%20Validation%20-%20How%20can%20it%20be%20done%20-%20ESUG.pdf