GxP-Agent: DAG Topology Enables Reliable Clinical Trial Programming with LLM Agents

GxP-Agent is a multi-agent system that encodes regulatory process ordering as a directed acyclic graph (DAG), decomposing clinical trial programming into 15 specialized nodes with validation gates to ensure CDISC compliance.

While traditional single-agent models fail completely (0%), GxP-Agent achieves 100% structural match and lifts weaker models like GPT-4.1 from 0% to 59.2%.

Systems like GxP-Agent can accelerate regulatory drug approvals in the region, reduce human errors in trial data preparation, and enhance clinical research efficiency.

Results are highly promising on CDISC-Bench, but further validation on broader datasets is needed before full clinical adoption, especially across diverse regulatory environments.