Trial Submission Studio

Read full text
Authors: Ruben Talstra
Cited by: 0

Abstract

Trial Submission Studio is an open-source desktop application that transforms clinical trial data into FDA-compliant CDISC formats. It provides multi-format output support (XPT V5/V8, Dataset-XML, Define-XML 2.1), intelligent fuzzy column matching with confidence scores, built-in CDISC Controlled Terminology validation, and cross-platform native applications for macOS, Windows, and Linux. All standards are embedded for offline use.

Publication details

Journal / source
Zenodo (CERN European Organization for Nuclear Research)
Publication date
4 January 2026