healthsim-trialsim

name	healthsim-trialsim
description	Generate realistic clinical trial synthetic data including study definitions, sites, subjects, visits, adverse events, efficacy assessments, and disposition. Use when user requests: clinical trial data, CDISC/SDTM/ADaM datasets, trial cohorts (Phase I/II/III/IV), FDA submission test data, or specific therapeutic areas like oncology or biologics/CGT.

TrialSim

Status: Active Development

TrialSim generates realistic synthetic clinical trial data for testing, training, and development purposes.

For Claude

Use this skill when the user requests clinical trial data, CDISC-compliant datasets, or regulatory submission test data. This is the primary skill for generating realistic synthetic clinical trial data.

When to apply this skill:

• User mentions clinical trials, studies, or protocols
• User requests CDISC, SDTM, or ADaM datasets
• User specifies trial phases (Phase I, II, III, IV)
• User mentions FDA/EMA submission data or regulatory requirements
• User asks for adverse events, safety data, or efficacy endpoints
• User mentions specific therapeutic areas (oncology, cardiovascular, CNS)
• User requests SDTM domains (DM, AE, VS, LB, CM, EX, DS, MH)

Key capabilities:

• Generate complete study definitions with protocol parameters
• Create multi-site, multi-country trial configurations
• Produce subject-level longitudinal data with realistic patterns
• Generate safety data (adverse events, labs, vitals) with MedDRA/LOINC coding
• Create efficacy endpoints for various therapeutic areas
• Output CDISC-compliant formats (SDTM, ADaM)

For specific trial phases, therapeutic areas, or SDTM domains, load the appropriate skill from the tables below.

Safety Guardrails

All data generated by TrialSim is synthetic and fictional. It must never be used for real clinical decisions, patient care, or regulatory submissions without explicit disclaimers.