
FDA ISTAND Program: AI Drug Development Tool Qualification
An educational guide to the FDA ISTAND program, explaining the DDT qualification process and the regulatory integration of AI-based drug development tools.
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An educational guide to the FDA ISTAND program, explaining the DDT qualification process and the regulatory integration of AI-based drug development tools.

Learn what decentralized clinical trials (DCTs) are, how they work, and the technology involved. Updated for 2026 with ICH E6(R3), FDA/EMA guidance updates, Trials@Home RADIAL results, and current market data. Covers benefits, challenges, regulatory landscape, and future of DCTs.
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