Articles tagged with “regulatory-submission”

A Guide to CDISC Standards: Understanding SDTM and ADaM

Learn the essential CDISC standards for clinical trial data. This guide explains the SDTM and ADaM data models, their structure, and use in regulatory submissio

40 min read

11/19/2025

cdisc sdtm adam clinical data standards clinical trials regulatory submission data mapping fda

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.

40 min read

11/14/2025

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

Git Version Control for FDA and IEC 62304 Compliance

Examines how to apply Git version control workflows to satisfy FDA compliance, covering traceability, audit trails, and standards like 21 CFR Part 11 & IEC 62304.

50 min read

8/26/2025

git fda compliance version control iec 62304 21 cfr part 11 medical device software regulatory submission traceability