ACRO urged the FDA to include contract research organizations directly in the agency’s AI trial pilot for real-time clinical trials and AI-enabled optimization of early-phase studies. The Association of Clinical Research Organizations argued that CROs should be designated participants rather than treated as subcontractors visible only through a sponsor relationship. In submissions to the FDA’s pilot effort, ACRO cited its global footprint across clinical trials—reporting extensive study and patient-volume involvement in 2025—positioning CROs as stakeholders with practical “line of sight” into how data and workflows operate across geographies. The FDA’s initiative, unveiled as part of broader RTCT assessment work, seeks input through a request for information and is intended to examine how regulators can maintain patient safety, data integrity, and evidentiary standards while supporting innovation. ACRO also called for structured workshops to sustain regulator–industry dialogue as the pilot rolls out, recommending a 18-to-36 month pilot duration to allow iterative learning and correction.