Open Source Technologies in Regulatory Submissions

From PHUSE Wiki
Revision as of 17:53, 3 March 2020 by Elimiller (talk | contribs) (Created page with "===Abstract=== While interoperability and standardization have been goals of the pharmaceutical data science industry for years, much of the work to create and validate a subm...")
(diff) ← Older revision | Latest revision (diff) | Newer revision → (diff)
Jump to: navigation, search

Abstract

While interoperability and standardization have been goals of the pharmaceutical data science industry for years, much of the work to create and validate a submission package is done manually or with proprietary software. Integrating tabular study data, study metadata, STF data, and visualizations are low-hanging fruit for a collaborative industry solution. Open-source tools have matured in their reliability and flexibility. This <paper/poster> will explore their emerging use in regulatory submissions. The topics of tools that assist in creating a submission package, the cost of these tools, and the necessary controls and validation need to create and maintain a complaint eCTD package will be discussed.

Team Members

  • Eli Miller
  • James Gunter