healthsim-trialsim

Generate regulatory-grade synthetic clinical trial data across SDTM domains.

1|Updated Jan 9, 2026
One-click install
npx skills add https://github.com/mark64oswald/healthsim-agent --skill healthsim-trialsim
Or copy as Structured Prompt for Agent
Please help me install this Agent Skill.
Skill: healthsim-trialsim
Source: https://github.com/mark64oswald/healthsim-agent/tree/main/skills/trialsim
Command: npx skills add https://github.com/mark64oswald/healthsim-agent --skill healthsim-trialsim

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes references (resource) components.

What problem does it solve?

Health research teams often struggle to produce compliant, synthetic trial datasets for testing analytics pipelines and regulatory submissions. This Skill provides a self-contained way to generate SDTM-ready trial data across multiple domains (DM, AE, CM, EX, LB, VS, MH, DS) with realistic epidemiology and study design patterns.

Core Features & Use Cases

  • SDTM-compliant data generation: Create canonical JSON/SDTM datasets ready for API testing or regulatory QA.
  • End-to-end trial scenarios: Simulate Phase I–Phase III trials across Oncology, CV, CNS, CGT with phase-appropriate endpoints.
  • Regulatory-ready outputs: Produce data suitable for SDTM/ADaM formats, including domain links and provenance.

Use Case: Generate a Phase 3 oncology SDTM dataset with 200 subjects, including DM, AE, LB, and DS records, and export as JSON for system validation.

Quick Start

  • Launch HealthSim TrialSim with a natural-language prompt like: "Generate a Phase 3 oncology trial with 200 subjects."

Frequently Asked Questions about healthsim-trialsim

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I generate synthetic clinical trial data for SDTM domains?

To generate synthetic clinical trial data for SDTM domains, you can use a natural-language prompt to simulate Phase I–III trials across therapeutic areas like oncology, creating canonical JSON datasets with realistic epidemiology for domains such as DM, AE, and LB.

Can I simulate Phase 3 oncology trial datasets with SDTM mappings?

Yes, you can simulate Phase 3 oncology trial datasets with complete SDTM mappings. The generation process supports phase-appropriate endpoints and produces regulatory-ready outputs suitable for SDTM and ADaM formats across oncology, cardiovascular, CNS, and CGT trials.

What is the best way to create regulatory-ready synthetic data for clinical trial validation?

The best way to create regulatory-ready synthetic data for clinical trial validation is to generate SDTM-compliant datasets with realistic study design patterns. This approach produces canonical JSON outputs with domain links and provenance suitable for API testing and regulatory QA.

Which SDTM domains are supported when generating synthetic clinical trial datasets?

Supported SDTM domains when generating synthetic clinical trial datasets include DM, AE, CM, EX, LB, VS, MH, and DS. These domains are generated with realistic epidemiology and study design patterns to ensure comprehensive trial simulation.

Does synthetic clinical trial data generation work for Cell and Gene Therapy studies?

Yes, synthetic clinical trial data generation works for Cell and Gene Therapy (CGT) studies. The generation process supports end-to-end trial scenarios across CGT, oncology, cardiovascular, and CNS therapeutic areas from Phase 1 through Phase 3.