Comment from Certara Inc.
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Summary: Certara Inc. supports the FDA's proposed pilot program for AI-enabled optimization of early-phase clinical trials, emphasizing that the program should focus on improving the quality and timeliness of development decisions rather than just data flow. They recommend integrating AI with model-informed drug development (MIDD) frameworks and establishing clear standards for decision-level traceability, trustworthiness, and comparative evaluation.
Certara appreciates the opportunity to comment on FDA's proposed pilot program for AI-enabled optimization of early-phase clinical trials. Please see attached comment submitted by Certara Inc. regarding Docket No. FDA-2026-N-4390.