Beerse, Belgium
11th September 2019
Presentation Title: Review Safety Signals from Interim or Submittable SEND Datasets Using MySEND
Roche-PointCross Joint Presentation
Presentation on “Review Safety Signals from Interim or Submittable SEND Datasets Using MySEND” by Nicolas Philippe, PointCross Life Sciences and Dr. Dragomir Ivanov Draganov, Roche
Support for SEND DART IG 1.1 as per FDA Data Standards Catalog Effective March 15, 2021: Support for SEND DART... read more
As some may have heard, the FDA released their bi-annual update to the Technical Conformance Guide earlier this year.... read more
CDISC opened public review for SENDIG v4.0 in April 2026, with publication targeted for Q4 2026. While the FDA has... read more
PointCross has reviewed numerous SEND datasets prepared for test submissions to the FDA and has worked with the FDA... read more