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At AlphaLife Sciences, we know that getting life-changing therapies to patients relies on accurate, compliant, and timely documentation. For clinical operations, regulatory affairs, and medical writing professionals, the documentation lifecycle—from drafting protocols to compiling Clinical Study Reports (CSRs)—can be complex and time-intensive.

That’s why AuroraPrime RMA (Regulatory & Medical Authoring) was built: to transform complexity into clarity using advanced Generative AI. This platform is not just an editing tool; it’s an integrated engine for regulatory document generation. With the release of AuroraPrime RMA 2025.10.26, we are rolling out significant enhancements designed to provide you with greater control over data presentation, streamline AI content customization, and drastically reduce the time spent on manual quality control (QC). AuroraPrime RMA continues to evolve as a truly game-changing tool for compliant content creation.

Here are the most impactful updates designed to make your regulatory lifecycle faster, easier, and more reliable.

Smarter Content Generation and Streamlined Workflow

The core functionality of AuroraPrime RMA has been optimized for speed and consistency, allowing writers to focus less on administrative setup and more on strategic content review.

Optimized Document Setup

We’ve introduced changes that simplify how you start and finalize your projects:

• Document Type Association: When creating a new document, you must now first specify its document type (e.g., CSR, Study Protocol). Your subsequent writing projects will be automatically linked to that specific type, ensuring better organization and structure. If you are a Project Creator, any new writing project you create will automatically be linked to the specified document type.

• Simplified AI Rule Configuration: Setting up rules for section content generation is now easier than ever. When using the current document as the information source, AuroraPrime RMA will automatically determine the necessary content generation method, eliminating the need for you to manually select it.

• Faster Document Finalization: Cleanup just got simpler. You can now use the new Clear Writing Instructions button to remove all writing instructions in one step. This speeds up the finalization process, and note that the Convert to Normal Content action will no longer convert these instructions into normal content.

Unprecedented Control Over TFL Data Presentation

For medical writers compiling CSRs, managing and formatting Tables, Figures, and Listings (TFLs) is often the most time-consuming task. This release provides a powerful suite of features to ensure TFL data is presented accurately, contextually, and consistently.

Enhanced Batch Processing and Customization

We’ve delivered updates that drastically cut down the time spent manually customizing TFL summaries:

• Batch-Apply Prompts for Consistency: When batch-generating TFL Summaries, you can now apply the same additional prompt to all generation configurations simultaneously. Previously, this required tedious selection one configuration at a time. This feature saves significant time and ensures consistent tone or focus across all generated summaries.

• Note: This batch application capability is currently supported only for Batch Generating TFL Summary, not for standard Content Generation.

• Precision Filtering by Hierarchy: You can now apply a hierarchical level filter when generating TFL summaries. This means you can specify that the generated summary only includes data up to a selected level in the source table, providing tight control over the final content and ensuring reporting precision.

Dynamic TFL View Editing

The TFL View Editor now offers advanced formatting features that enhance readability and compliance:

• Merging Related Columns: You can now merge related columns (for instance, separate columns for 'N' and '%' values) into a single, cohesive column. The feature supports text concatenation using the extended concept of Derived Columns (previously known as Calculated Columns).

• Batch-Merging Similar Rows: To format large tables efficiently, you can now select and batch-merge multiple rows with similar patterns all at once. This gives you full control over how rows are combined and formatted based on your specified grouping preferences.

• Contextual Clarity: Both the In-Text TFL list and the TFL Summary list now clearly display the name of the immediate section that each item belongs to. This provides immediate context for writers and reviewers, speeding up verification.

Streamlining Study Protocol Development

For professionals involved in clinical operations and protocol authoring, we’ve focused on improving structure and assessment management:

• Comprehensive Assessment Identification: When identifying assessments in the Schedule of Activities (SOA), you will now see all assessments defined in the system knowledge base plus any additional assessments defined in the SOA itself. While predefined assessments are automatically selected, you can easily manually select others, ensuring your protocol is comprehensive and accurate.

• Improved Protocol Organization: Section numbering has been added to section models, enabling easier sorting of sections within the protocol.

• Consistent Batch Generation: The workflow for batch section content generation has been optimized with a more streamlined process and a consistent, intuitive interface.

What’s Next for AuroraPrime RMA?

These enhancements in Release 2025.10.26 reaffirm AuroraPrime RMA's commitment to delivering AI tools that are not only powerful but also precise and user-friendly. We are continually building on the foundation of compliance and efficiency.

The features highlighted above—especially the advanced TFL controls and streamlined content generation workflows—are designed to provide critical time savings and quality improvements to your most sensitive regulatory documentation.

Ready to experience the future of regulatory authoring?

Check out the full release notes for 2025.10.26 and schedule a demonstration to see these powerful new features in action!