A prepared place to start
The upcoming release introduces Project Scaffolds as the new name for Project Templates. The change reflects what a scaffold contains: document templates, predefined folders, and supporting materials such as job aids, style guides, and QC checklists. Creating a writing project from a scaffold copies and initializes those materials, so the team can begin in a prepared workspace.
For organizations using Veeva, document links also become more selective. Teams can choose which individual documents to push to Veeva. Once linked, Veeva holds the authoritative version, and Edit in Office routes writers to that document in Veeva.
More control around generation
The release brings additional prompts into one place. Writers can manage document-wide prompts, section-specific prompts, and personal prompts in My Library. A section inherits applicable prompts from its parent sections and the document level, with a preview of the combined instructions. Template prompt changes can also be applied to existing rules in the current template while preserving prompts edited in individual rules.
For CSR teams, initial-draft setup gains a way to select existing tables, figures, and listings (TFLs) directly. Writers can add the TFLs manually or use AI Recommendation to help configure mappings. When a mapping file does not identify a document section, RMA can recommend a section for review. Before a batch update, writers can inspect and adjust each selected content block's settings.
New paths for safety and nonclinical writing
The September release is planned to support an initial Risk Management Plan draft from supplied materials. The workflow starts with a template in the web portal and continues in the Word add-in. DSUR and PBRER creation also moves to a template-based start in the portal before authoring continues in Word.
For Module 2.4, writers will be able to generate an initial Nonclinical Overview from associated documents, including Module 2.6 summaries. The workflow includes a review of the proposed document structure and content configuration before draft generation. In Modules 2.4 and 2.6, generated content can reuse citations in Word's citation library and link references to generated tables through Word fields. A References section is not populated automatically.
A CMC workflow with guidance closer to the work
CMC teams will be able to create multiple target documents from selected templates and review prefilled attributes before creating them. New project scaffolds include built-in industry guidance for Quality and Quality Overall Summary authoring; teams can also upload company guidelines for extraction. Strategy Analysis becomes a separate step that saves its result as a document for later use.
These are selected highlights from the planned AuroraPrime RMA 2026.09.27 release, not the full change list. We will share the complete release notes when the release is available. To discuss how the upcoming workflows fit your writing process, contact AlphaLife Sciences.
