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Published January 5, 2026 | Version 0.0.1-alpha.8
Software Open

Trial Submission Studio

Authors/Creators

Description

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.

Notes

ALPHA SOFTWARE - Under active development. Not intended for production regulatory submissions.

Files

rubentalstra/Trial-Submission-Studio-v0.0.1-alpha.10.zip

Files (41.3 MB)

Additional details

Related works

Is documented by
Other: https://rubentalstra.github.io/Trial-Submission-Studio/ (URL)
Is supplement to
Software: https://github.com/rubentalstra/trial-submission-studio (URL)

Software

Repository URL
https://github.com/rubentalstra/Trial-Submission-Studio