Roadmap

Development plans for Trial Submission Studio.

Note

This roadmap reflects current plans and priorities. Items may change based on community feedback and project needs.

Current Focus

Features actively being developed:

• Complete SDTM transformation pipeline
• Dataset-XML export
• Define-XML 2.1 generation
• Comprehensive SDTM validation rules
• Full export workflow

Short-term

Features planned for near-term development:

• Batch processing (multiple domains)
• Export templates and presets
• Improved error messages and validation feedback
• Session save/restore
• Mapping templates (save and reuse mappings)

Medium-term

Features planned after core functionality is stable:

• ADaM (Analysis Data Model) support
• SUPP domain handling improvements
• Custom validation rules
• Report generation
• Undo/redo functionality improvements

Long-term

Features for future consideration:

• SEND (Standard for Exchange of Nonclinical Data) support
• Batch CLI mode for automation
• Define-XML import (reverse engineering)
• Plugin system for custom transformations
• Multi-study support

Completed

Features that have been implemented:

• Core XPT read/write (V5 + V8)
• CSV ingestion with schema detection
• Fuzzy column mapping engine
• Controlled Terminology validation
• Desktop GUI (egui/eframe)
• SDTM-IG v3.4 standards embedded
• Controlled Terminology (2024-2025)
• Cross-platform support (macOS, Windows, Linux)

How to Contribute

We welcome contributions! See the Contributing Guide for details.

Working on Roadmap Items

If you’d like to work on a roadmap item:

1. Check if there’s an existing GitHub Issue
2. Comment to express interest
3. Wait for maintainer feedback before starting work
4. Follow the PR guidelines

Suggesting New Features

Have ideas for the roadmap?

1. Check existing issues and discussions
2. Open a new issue or discussion
3. Describe the feature and use case
4. Engage with community feedback

Prioritization

Features are prioritized based on:

1. Regulatory compliance - FDA submission requirements
2. User impact - Benefit to most users
3. Complexity - Development effort required
4. Dependencies - Prerequisites from other features
5. Community feedback - Requested features

Versioning Plan

Stay Updated

• Watch the GitHub repository
• Check Releases
• Follow Discussions