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For clinical operations, regulatory affairs, and medical writing professionals, speed and compliance are not just goals—they are mandates. Regulatory document generation has long been a complex, time-consuming process, but at AlphaLife Sciences, we are continually evolving AuroraPrime Regulatory & Medical Authoring (RMA) to change that narrative.

The latest release of AuroraPrime RMA isn't just an update; it's a significant leap forward in empowering you with unprecedented control over generative AI, ensuring compliance consistency, and maximizing your team's throughput. We’ve baked in features designed to transform documentation from a necessary bottleneck into a source of competitive speed and verifiable quality.

Here’s a look at the powerful new ways AuroraPrime RMA helps you reclaim control over your most critical documents.

Mastering the AI Workflow: Precision and Confidence

The true value of GenAI lies in its ability to accelerate drafting, but only if you maintain absolute control over the quality and accuracy of the output. This release focuses on giving you tools for surgical precision when drafting complex sections like study protocols or clinical summaries.

1. Zero-Drafting the CSR Synopsis

Creating a high-quality Clinical Study Report (CSR) synopsis demands immense time and focused effort. AuroraPrime RMA now offers an automated solution that significantly speeds up this critical step.

• Generate Structured Synopses: Users can now automatically generate a structured, high-quality CSR synopsis using AI.

• AI-Assisted Fine-Tuning: You maintain full control: you can preview the full synopsis before insertion, integrate it directly into the CSR, and then further refine specific sections, either manually or via AI-assisted regeneration.

2. Sharper Content Generation Through Iteration

For highly technical components, like the statistical analysis section of a study protocol, achieving the perfect result often requires fine-tuning the inputs.

• Revision Before Regeneration: When generating content for specific sections (currently available for the study protocol document type), you now have the power to revise, modify, or delete unsatisfactory answers within GenAI before initiating the content regeneration process. This ensures that the AI is working with the most precise information, leading to higher-quality output faster.

• Instant Quality Control: Say goodbye to painstaking manual comparisons. When regenerating content, the AI Tasks pane now displays a "diff" view, allowing you to instantly compare the newly regenerated text against the corresponding content already inserted into your document. This enhancement dramatically speeds up the quality control and review processes.

Locking Down Regulatory Quality: Consistency Simplified

Document consistency is non-negotiable in regulatory submissions. Minor errors in terminology or abbreviation usage can lead to costly delays. We've introduced tools to automate quality assurance checks that previously relied on manual review.

Ensuring Terminology Compliance

A key addition to this release helps enforce consistency, particularly regarding abbreviations.

• Full Term on First Mention, Then Abbreviations Only: A new command set is available that lets you establish rules that automatically identify abbreviations and ensures the full term is consistently spelled out only upon its first occurrence in the document. (Note: This feature is currently available for protocol and lay summary document types).

Handling the Heavy Lifting: Data Summaries at Scale

Clinical trials are generating ever-increasing amounts of data. This release optimizes how you manage and summarize key clinical data, offering increased capacity and flexibility.

Accelerated TFL Summarization

We have streamlined our TFL (Tables, Figures, and Listings) summary generation workflows to handle larger studies with greater efficiency.

• Increased Capacity: You can now include up to 10 TFLs when generating summaries, effectively doubling the previous limit of 5.

• Optimized Batch Generation: The underlying workflow for batch generating summaries across multiple TFLs has been streamlined for increased speed and efficiency.

• Flexible Assignment: While the system automatically assigns TFL summaries to the appropriate sections (like Safety or Efficacy), you now have the critical option to manually specify the desired section if needed, providing ultimate organizational control.

Smart Data Synchronization

Managing clinical data within in-text tables requires flexibility. When synchronizing source data into these tables, you now have the choice to either retain or clear unmapped data during backfilling or replacement. This gives you granular control over data integration and cleansing within your documents.

Smarter Operations: Visibility and Error Prevention

For organizational leaders and administrators, understanding platform usage and preventing common workflow errors are critical for maximizing investment and driving adoption.

Operational Insight: The RMA Usage Dashboard

Administrators can now leverage powerful new operational intelligence. A new RMA Usage Dashboard is available under Org Administration in the AuroraPrime web admin portal. Org Admins can use this feature to view aggregated and detailed usage reports, broken down by document type, within specified time periods. This insight is key to identifying adoption trends and resource needs.

Proactive Usability Warnings

To improve user workflow and proactively prevent errors, the Add-in now provides clear, context-aware banners. These banners alert users if the document is detected as being in Reviewing (tracking) mode (which is generally not recommended for use with the Add-in) or if the document is currently read-only. These visual cues ensure users are always working in the optimal environment.

Ready to Accelerate Your Documentation Cycle?

The latest release of AuroraPrime RMA provides the advanced control, compliance tools, and operational efficiencies your teams need to excel. We are committed to ensuring your regulatory documentation process is not just compliant, but genuinely efficient.

Dive into these new capabilities today. Check out the full release notes for all details and instructions, or reach out to our team to activate new, powerful features like automated CSR Synopsis generation.