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