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Already a game-changer in regulatory and medical content generation, the AuroraPrime Regulatory & Medical Authoring (RMA) platform continues to evolve—pushing the boundaries of what AI can do. We’re excited to unveil the latest AuroraPrime RMA release, packed with powerful new enhancements designed to empower clinical operations, medical writing, and regulatory affairs teams like never before.

Elevating AI-Driven Content Generation and Quality Control

The core of AuroraPrime RMA lies in its intelligent automation, and this release introduces significant leaps in how AI supports your writing process:

• Smarter Summarization for Clinical Study Reports: The CSR efficacy TFL summarization upgrade is a standout feature, allowing the system to generate detailed summaries for efficacy Tables, Figures, and Listings (TFLs). What makes this truly intelligent is its ability to factor in crucial study design elements, including objectives, endpoints, rationale, and statistical analysis methods, ensuring your summaries are not just accurate, but contextually rich.

• Interactive AI Guidance for Section Generation: Imagine your AI not just generating content, but collaborating with you. With section generation interactive questions support, the AI can now ask you questions in real-time during content generation for sections, guiding you through the process and ensuring the output perfectly aligns with your vision. This functionality is currently enabled in Statistical Consideration sections.

• Transparent AI Rationale: Ever wondered how the AI arrived at a specific piece of content? The new section generation steps view provides a unified user interface that displays the AI's rationale and detailed information extraction process, offering unprecedented transparency and building greater trust in AI-generated drafts.

• Leveraging Curated Knowledge: When configuring content generation rules for sections, you can now reference a curated list of assessment sections extracted directly from historical documents within your knowledge base, ensuring consistency and accuracy across your portfolio.

Boosting Document Consistency and Workflow Efficiency

Consistency and streamlined workflows are paramount in regulatory affairs. This release delivers key improvements that make daily tasks smoother and more compliant:

• Ensuring Document Consistency with Enhanced Style Mapping: Maintaining consistent styling across vast numbers of documents can be a challenge. Our new document style mapping feature allows you to map existing Word document styles to a standardized set when creating AI-enabled templates. This ensures that medical writers can apply styles consistently, leading to polished and professional outputs every time.

• Flexible In-Text TFL Caption Formats: Regulatory requirements can vary, and so should your document's flexibility. The in-text TFL caption format configuration now allows for adopting different caption formats, ensuring you can meet diverse requirements without manual workarounds.

• Comprehensive Footnote Handling for Multi-Source TFLs: When an in-text TFL draws from multiple sources, handling footnotes can be complex. This improvement ensures that if footnotes differ across sources, all distinct footnotes will now be included in the in-text TFL, providing a complete and accurate picture.

• Batch Updates for TFL Footnote Sources: We've enhanced the ability to batch update TFL sources in footnotes, now supporting additional identifiers such as 'Sources:', 'Reference:', and 'References:', making large-scale updates more efficient.

• Toggle Writing Instructions Visibility: To keep your drafting clean, the writing instructions display option allows you to easily show or hide writing instructions in the document, ensuring they are visible when needed for guidance but hidden for final drafts.

A Step Forward in Collaborative and Intelligent Authoring

AuroraPrime RMA is designed to work with you, streamlining every stage of your clinical development lifecycle. This latest release underscores our commitment to providing a powerful, flexible, and scalable solution that enhances quality, accelerates compliance, and frees your teams to focus on innovation.

We believe that the future of life sciences R&D hinges on intelligent, integrated solutions. AuroraPrime RMA is that future, enabling enterprises to achieve transformative outcomes through AI excellence.

Ready to experience the next evolution of regulatory and medical authoring?

Explore the full release notes or Contact us for a personalized demo and discover how AuroraPrime RMA can revolutionize your documentation process today.