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Published by Stephy Publishers, this mini review of AI application in Clinical Trials synthesizes regulatory guidance and empirical evidence from 2020-2025 publications to examine how AI accelerates both drug and device trials and proposes a strategic implementation framework. This work represents data from systematic research in PubMed, arXiv, Scopus, and regulatory archives (FDA, EMA) using structured search strings from approximately 450 initial publications. A four-pillar framework integrating: (1) Predictive Intelligence; (2) Automation; (3) Integration of R&D platforms and regulatory systems; and (4) Transparency via explainable AI for regulatory trust – is presented in this article.  By purchasing this article on AIiIA site, the user gets a bonus consulting session with the author, and AIiIA founder, Irina I. Agoulnik.

Intelligent Acceleration: Redefining Clinical Trials for Drugs & Devices with AI

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