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Evolving Legal Frameworks for AI-Assisted Clinical Trials

AI has rapidly progressed from being merely a computational helper to a functional co-researcher in clinical trials. Nowadays, algorithmic methods are entailed in protocol development, patient selection, adaptive drug dosing, and real-time safety evaluation. However, Indian law still anticipates a research environment run solely by human researchers. The discrepancy between technology’s potential and its legal acknowledgement has resulted in a multifaceted regulatory scenario that needs healthcare regulatory compliance lawyers and healthcare data privacy law firms.

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