Articles tagged with “define-xml”

SEND Datasets Guide: FDA Nonclinical Submission Standards

Learn about CDISC SEND datasets for FDA nonclinical submissions. This guide explains SDTM framework alignment, SENDIG rules, and regulatory compliance timelines

25 min read

4/20/2026

send datasets fda nonclinical submissions cdisc standards sendig sdtm framework define-xml toxicology data nsdrg

CDISC Standards: How They Work with SDTM & ADaM Examples

Learn about CDISC standards for clinical trial data. This guide explains SDTM, ADaM, CDASH, and Define-XML with concrete examples for regulatory submissions.

45 min read

11/14/2025

cdisc sdtm adam clinical trial data data standards regulatory submission cdash define-xml clinical data management