Regulatory agencies and trial‑tech vendors demonstrated pilot programs using AI to automate repetitive checks and surface critical issues. European regulator BfArM and LORENZ showcased VerifAI pilots that automate validation checks on thousands of Type IA variations, reducing manual re‑work. The pilots stress deterministic, rule‑based outcomes to build reviewer trust. At the trial site level, Medable launched an Agentic AI tool aimed at principal investigators to summarize and triage electronic clinical outcome assessment data, reducing manual reconciliation burdens. The product emphasizes human‑in‑the‑loop controls and audit trails to meet regulatory oversight needs. Both developments reflect a pragmatic turn: AI is being deployed to accelerate routine regulatory and site workflows rather than to replace expert judgment, with governance and transparency cited as prerequisites for adoption.
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