Trial Submission Studio

Transform clinical trial data into FDA-compliant CDISC formats

Documentation • Download • Report Bug • Discussions

Caution

ALPHA SOFTWARE - Active development. Not for production regulatory submissions. See Disclaimer.

Automatic domain discovery from your clinical trial data

Features

Feature	Description
Multi-format Output	XPT V5/V8, Dataset-XML, Define-XML 2.1
Intelligent Mapping	Fuzzy column matching with confidence scores
CDISC Validation	Built-in Controlled Terminology checks
Cross-platform	macOS, Windows, Linux native apps
Offline	All standards embedded, no internet required
Open Source	MIT License, free forever

Table of Contents

• Installation
• Quick Start
• Supported Standards
• Documentation
• Architecture
• Contributing
• License

Installation

Download the latest release for your platform:

Platform	Architecture	Download
macOS	Apple Silicon (M1/M2/M3+)	.dmg
macOS	Intel (x86_64)	.dmg
Windows	x86_64	.exe
Windows	ARM64	.exe
Linux	x86_64	.AppImage
Linux	ARM64	.AppImage

Build from Source

# Requires Rust 1.92+
git clone https://github.com/rubentalstra/trial-submission-studio.git
cd trial-submission-studio
cargo build --release
cargo run --package tss-gui

Quick Start

1. Import your CSV source data
2. Select target SDTM domain (DM, AE, VS, etc.)
3. Map columns using intelligent suggestions
4. Validate against CDISC standards
5. Export to XPT, Dataset-XML, or Define-XML

Supported Standards

Standard	Version	Status
SDTM-IG	v3.4	Supported
Controlled Terminology	2024-2025	Supported
ADaM-IG	v1.3	Planned
SEND-IG	v3.1.1	Planned

Documentation

Read the full documentation →

• Getting Started
• User Guide
• CDISC Standards
• Architecture

Architecture

6-crate Rust workspace designed for modularity:

tss-gui            → Desktop application (Iced 0.14.0)
tss-submit         → Mapping, normalization, validation, export
tss-ingest         → CSV loading
tss-standards      → CDISC standards loader
tss-updater        → Auto-update functionality
tss-updater-helper → macOS update helper

Contributing

We welcome contributions! See CONTRIBUTING.md for guidelines.

• Development Setup
• Coding Standards
• Pull Request Guidelines

Acknowledgments

Built with:

• CDISC standards
• Polars DataFrame library
• Iced GUI framework
• RapidFuzz string matching

License

MIT License - Copyright (c) 2026 Ruben Talstra

Code Signing

Windows releases are signed for security. Free code signing provided by SignPath.io, certificate by SignPath Foundation.

See our Code Signing Policy and Privacy Policy.