Comment from Medrio Inc.

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Summary: Medrio, a software and services vendor for clinical trial technology, supports the FDA's pilot program for AI-enabled optimization of early-phase clinical trials. They advocate for including technology vendors as formal collaborators, establishing clear regulatory guardrails for data privacy and signal response, and ensuring that AI remains a tool to inform human clinical judgment rather than replace it.
Medrio appreciates the opportunity to provide our thoughts on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. We look forward to continued collaboration with the FDA and seeing this important Pilot Program implemented. Please find our response as an attached PDF file.

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