Architecture & Design Decks

5-pass rule engine annotates every shell row to dataset.variable.where.statistic. Generates paired SAS deliverable + R validator + annotated PDF.

Upload raw CSV/SAS7BDAT → auto-classify domain → LLM spec → SAS+R+Python code → execute → validate. Accuracy gate: DeepSeek → Opus only on failure.

4-tab R Shiny QC dashboard. Discrepancy log, sign-off tracking, progress gauges. append-only CSV audit trail. bslib v5 + reactable + plotly.

PRR/ROR/Chi² signal detection (Evans 2001). 5 tabs: AE overview, explorer, signal table, KM time-to-first-AE, Subject Gantt. 200 subjects, 681 AEs.

Modular 7-tab R Shiny app on CDISCPILOT01. Swimmer, waterfall, spaghetti, KM, SOC/PT incidence. NS/moduleServer/R6/bindCache patterns throughout.

Same derivation in 3 languages, proven identical, with AI code generation.

Production R packages with a live demo running real R on edit.

Python re-derives counts and reconciles cell by cell against production RTF.

One shell spec → SAS deliverable + R validator + parity check.

6-agent pipeline: raw data → 8 SDTM datasets + SAS + MCP tools.

RAG Q&A over CDISC standards, email-gated, with references.

Shell → SAS + R via RAG, browser-side sanitization, GAMP 5 audit.

YAML ARS spec → HTML + RTF + Dataset-JSON, fully traceable.

7 clinical tools exposed to AI agents over Model Context Protocol.

Complete end-to-end oncology submission: CRF → SDTM → ADaM → TLF → define.xml, with 3 live R analyses.

Validates CDISC Analysis Results Standard (ARS) JSON against a 21-rule conformance engine — structure, references, controlled terminology — with severity-graded findings and CDISC citations.

Import an ARS JSON spec and render the table/listing shell instantly — spec-to-output preview with a sample fixture, no SAS required.

Standards and practical guidance for annotating Case Report Forms for CDISC compliance.

How modern automation transforms ADaM dataset creation — from manual programming to spec-driven generation.

How AI agents are reshaping clinical programming workflows — code generation, QC, and regulatory compliance.