Weave, in collaboration with Takeda, has published a first-of-its-kind study — Human–AI Collaboration Increases Efficiency in Regulatory Writing.

The study compared traditional regulatory drafting with AI-augmented drafting on the Weave Platform. Key findings include:

• ~97% reduction in first-drafting time — from ~100 hours to as little as 2.6–3.7 hours for large IND nonclinical written summaries
• No critical regulatory errors identified in AI-generated drafts during independent QC assessments
• Opportunities for refinement in clarity and conciseness, highlighting the continued importance of expert human reviewers

These results reflect Weave’s philosophy: AI accelerates, but human expertise ensures accuracy. Every document is guided and finalized by regulatory experts to meet the highest standards of quality.

Complete the form to download your copy from Weave or view online at https://arxiv.org/abs/2509.09738.

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