The 2026 CDISC AI Innovation Challenge winners present today in Denver. None published code — except one adjacent R package. We read synadam's source and compare it to our own synthetic ADaM pipeline.
From chat to autonomous workflow: how the Model Context Protocol standardizes what tools agents may touch, what an agent-native clinical pipeline looks like, and the guardrails that keep autonomy auditable.
AI pair programmers for ADaM, LLM-assisted tables, QC drafting — the production case ledger from 2024-2026, and the exact wall each case hit when the rubber met validation.
NL-to-CDISC generation, LLM-built analysis apps, auto slide decks — how close is the fully automatic submission, and which bottleneck is regulatory rather than technical?
A tiered survey of LLM evidence in clinical trial statistical programming: benchmarked results, promising single-team studies, vendor hype, and open gaps for 2026–2027.
Schema-only synthetic ADaM generation plateaus at 0.45 overall quality; enriching schemas from protocol/SAP/CRF knowledge graphs plus templates reaches 0.70.