Webinar - 100% Consistency Check of SEND Datasets Against Nonclinical Study Reports (NCSR) is Affordable and Quick
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If you are a sponsor and aware that the FDA presented a detailed and thorough webinar on September 12th, 2019, to be followed by another on March 20th2020, then you know that your SEND datasets may have significant consistency issues that render them non-reviewable without remedies. SEND studies must load on Janus. Additionally, they must be capable of reproducing the published Study Report Summaries taking grouping and timing variables into account.
This webinar provides a cost effective way of automating 100% checking of your SEND datasets against your toxicology reports. Download our open-source SRR (Study Report Reference file) specification and generate the SRR yourself. Or, ask us to do it for a fixed price of $3,000 per study report. We have the experience doing it for over 1,500 studies. Be sure that your FDA submissions can be reviewed confidently and accurately.