Welcome to Trial Submission Studio
Transform clinical trial data into FDA-compliant CDISC formats with confidence.
Trial Submission Studio is a free, open-source desktop application for transforming clinical trial source data (CSV) into CDISC-compliant submission formats.
Caution
ALPHA SOFTWARE - ACTIVE DEVELOPMENT
Trial Submission Studio is currently in early development. Features are incomplete, APIs may change, and bugs are expected. Do not use for production regulatory submissions.
Always validate all outputs with qualified regulatory professionals before submission to regulatory authorities.
See It in Action
Select your CDISC standard and open your study data:
Automatic domain discovery with intelligent column mapping:
Built-in validation against CDISC standards:
Quick Links
| New Users | Clinical Programmers | Developers |
|---|---|---|
| Installation | User Guide | Architecture |
| Quick Start | CDISC Standards | Contributing |
| System Requirements | Output Formats | Development Setup |
Key Features
| Feature | Description |
|---|---|
| Multi-format Output | XPT V5/V8, Dataset-XML, Define-XML 2.1 |
| Intelligent Mapping | Fuzzy matching for automatic column-to-variable mapping |
| CDISC Validation | Built-in controlled terminology validation |
| Cross-platform | Native GUI for macOS, Windows, and Linux |
| Offline Operation | All CDISC standards embedded locally |
Supported Standards
Currently Supported:
- SDTM-IG v3.4
- Controlled Terminology (2024-2025 versions)
Planned:
- ADaM-IG v1.3
- SEND-IG v3.1.1
Getting Help
- Documentation: You’re reading it! Use the sidebar to navigate.
- Issues: Report bugs on GitHub
- Discussions: Ask questions on GitHub Discussions
License
Trial Submission Studio is open source software licensed under the MIT License.