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AI-Assisted Dossier Drafting: Time and Quality Study

The Weave Time and Quality Study (July 2025), conducted with a Top 20 global pharmaceutical company, compared traditional human drafting with AI-assisted content generation for complex IND submission sections (Pharmacology 2.6.2, Pharmacokinetics 2.6.4, and Toxicology 2.6.6). Traditional drafting required roughly 100 FTE hours, while Weave enabled two pharma users to produce equivalent content in under 4 hours—a ~97% time reduction—without sacrificing quality. The platform accelerated work through instant first drafts, automated formatting, and rapid iteration, while human oversight ensured strategic alignment, organizational consistency, and nuanced decision-making. The study highlights that when supported by a clear evaluation rubric and applied to small, logical units of writing, AI-assisted workflows can dramatically improve efficiency while maintaining the rigor required for regulatory submissions.

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