This quarter, we focused on one goal: helping teams move through regulatory milestones with greater speed, accuracy, and confidence, without adding more work to their plates. The latest releases introduces AI capabilities that automatically verify your data and keep your documents up to date as new information becomes available, so you can stay inspection-ready at every stage of development.

The June 2025 update to the Weave Platform marks a significant step forward in supporting clinical-phase regulatory activities, expanding its capabilities across both clinical document generation and figure management.

This evolution deepens Weave’s role in accelerating the regulatory lifecycle from early development through submission. New functionality within the document workspace enables users to generate a broad range of clinical documents using uploaded source files in multiple formats. Clinical study dossiers can now be organized into dedicated folders, and AI Templates guide the drafting of key Module 5 content—including clinical study reports, protocols, and other trial-related documents—ensuring speed, consistency, and accuracy at scale. Enhancements to figure handling streamline the previously manual insertion process.

Figures are now automatically extracted from uploaded source files and made available for direct insertion into any document. This search-and-select experience is powered by the Data Room and reflects direct customer feedback, allowing teams to access and embed relevant visual content without leaving their workflow.

AutoIND April 2025 Release Summary

The April 2025 release of AutoIND delivers major enhancements to both AI Template workflows and the Data Room experience, deepening AutoIND’s position as the backbone of AI-native regulatory document generation. Key upgrades to the AI Template Engine include a unified Editor that allows seamless switching between template and content views, enabling rapid iteration and precise control over how and where content is generated. Users can now choose to generate an entire document or focus on individual sections, with the ability to insert new content beneath or in place of existing text. New logic within prompt blocks also allows prompts to run across all source files collectively—or on each file individually—providing more nuanced summaries. A new general-purpose template allows users to generate structured documents beyond the eCTD framework using any data in the Data Room.

Enhancements to the Data Room further simplify information access and interaction. Users can now upload entire folders while preserving structure, conduct semantic Deep searches with AI-generated relevance scoring, and preview file content directly in context. The newly renamed “Ask” tab (formerly “Explore”) supports multiple saved questions, editable queries, referenced responses, and file downloads. These features make it easier than ever to locate specific data and generate answers to Health Authority Questions or internal queries.

AutoIND February 2025 Release Summary

The February 2025 release of AutoIND introduces powerful enhancements to streamline IND document generation and management. Key updates include Data Tags, which allow more precise categorization of source files, ensuring that only the most relevant content is used in different parts of a submission. The Publishing v1 feature simplifies hyperlinking between sections, across documents, and to external sources, with automatic updates to maintain accuracy. Additionally, the Data Room Exploration functionality now includes an Overview Tab, offering a customizable, tabular view of all files, and an Explore Tab, where users can interact with AI to extract insights from their data. Other improvements include enhanced template flexibility, real-time content linking, and expanded support for document verification and organization. These updates significantly improve the efficiency and accuracy of regulatory submission preparation.

AutoIND December 2024 Release Summary

The December 2024 release of AutoIND introduces role-based access control, allowing organizations to assign Admin, Contributor, and Viewer roles with specific permissions. Admins can manage roles, set dossier visibility at various levels, and control user access. Multi-organization access enables seamless switching between client and home organizations for consistent branding and collaboration.

Key enhancements include granular version history, allowing users to preview and restore individual document versions, and table references, which now display source file citations for each table cell. Commenting features have been expanded, enabling users to add comments at any stage of document drafting.

Content templates for key nonclinical sections (2.2, 2.4, 2.6) now support structured content blocks, AI instructions, and dynamic values, improving flexibility. Data Room improvements include support for large PDF uploads (up to 1,500 pages), with clear indicators for truncated files. Additional fixes enhance document formatting, reference management, and template processing. These updates strengthen collaboration, control, and document accuracy across the IND submission process.