Using CDISC to Optimize Legacy and New Studies

CDISC Webinar, January 2016

As we approach the impending critical regulatory deadline for use of CDISC standards in FDA submissions, Formedix provides tips and tricks on how to leverage CDISC for the automated creation of annotated CRFs, CDISC Define.xml and datasets in CDISC Study Data Tabulation format (CDISC SDTM).

This presentation also shows how CDISC standards are best implemented at the start in new studies. It reveals metrics from case studies highlighting significant time and cost savings and an increase in overall quality in a CDISC driven end-to-end clinical trial.

What you’ll learn:

  • Understand core CDISC standards
  • How legacy/on-going studies can be converted to a CDISC submission format
  • Why CDISC standards are best implemented upfront in new trials
  • How to establish an end-to-end study library
  • Time and cost savings realized in CDISC implementations

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