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Published January 4, 2026 | Version v0.0.1-alpha.3
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

If you use this software, please cite it using the metadata from this file.

Files

rubentalstra/Trial-Submission-Studio-v0.0.1-alpha.3.zip

Files (36.6 MB)

Additional details