ardflow — ARS-driven TLF reviewer

Spec-driven clinical reporting in pure R: YAML → ARD → tables/figures → RTF + Dataset-JSON.

🛡️ Responsible AI & Governance

This platform is built around a 5-stage Human-in-the-Loop LLM Validation Framework: Input Validation → Constrained Generation → Automated QC → Human Sign-Off → Audit Trail.

Applied in production (ClinAssist v2, AI-powered TLF generator), this reduced QC iterations from 8 down to 1–2 per output — while keeping full audit traceability aligned to ALCOA+ and 21 CFR Part 11.

Interactive framework demo →

Analysis specification (YAML)

Datasets resolve from {pharmaverseadam} (CDISC pilot data). Powered by the ardflow R package.