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FDA has recently provided binding guidance on Clinical data submission standards, essentially adopting CDISC – SDTM / ADaM and related standards from October, 2016.(www.fda.gov/forindustry/datastandards/studydatastandards/default.htm)
Clindata Cloud is the First integrated COTS based "Clinical Data Management and
Analytics Portal" that automates the conversion of raw clinical data from disparate sources ( EDC Systems, Data bases..) into CDISC - SDTM / ADaM & SEND standards and analysis in real time.
This patent pending disruptive technology, helps Bio-Pharma, Medical Devices & Healthcare Product companies, bring their products to the market Faster, Cheaper (40%) and Better (ZERO FDA rejections due to data standards issues).
This first mover advantage along with a tremendous value proposition( see pitch deck) will establish us a dependable partner in the life sciences space.
