Generative AI holds major promise for clinical trials, but IQVIA stresses it must be applied with focus, restraint, and rigorous validation. Core principles include boosting productivity, reducing site and patient burden, optimizing outcomes, and enforcing safeguards. Six high-value areas stand out: patient safety review, compliance monitoring, inspection readiness, data quality, operational fluidity, and patient experience. Applications range from automating clinical ops plans, CRFs, and site reports to enhancing patient engagement via chatbots and home support. With careful guardrails, GenAI can transform trials while protecting safety and data integrity.

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