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In the fast-paced world of clinical development, efficiency is paramount. Generating high-quality regulatory documents, such as Clinical Study Reports (CSRs), protocols, and safety narratives, is a crucial but often time-consuming process. AuroraPrime Create, developed by AlphaLife Sciences, offers a solution by leveraging the power of generative AI to automate key aspects of medical writing, allowing medical writers to focus on higher-value tasks.

Streamlining Document Creation with AI

AuroraPrime Create integrates seamlessly with Microsoft Word 365 as an add-in, providing medical writers with familiar tools enhanced by powerful AI capabilities. It tackles the challenges of document creation on multiple fronts:

• Automated First Draft Generation: AuroraPrime Create can automatically generate initial drafts for a range of document types, including CSRs, protocols, lay summaries, and Investigator's Brochures. This automation significantly reduces the time and effort required to produce these documents, allowing medical writers to start with a solid foundation.

• Content Reuse and Summarization: The platform efficiently reuses content from existing documents, like protocols and Statistical Analysis Plans (SAPs) for CSRs. For data-intensive sections, AuroraPrime Create synchronizes Table, Figure, and Listing (TFL) data with placeholders and automatically generates summaries. This ensures accuracy and consistency while minimizing manual effort.

• Effortless Template Configuration: AuroraPrime Create provides flexible, AI-powered templates that can be easily adapted to various therapeutic areas, disease areas, and study types. The platform's no-code interface allows internal teams to create, configure, and manage templates independently, reducing reliance on vendor support and accelerating setup times.

• Seamless Ecosystem Integration: As a Microsoft Word add-in, AuroraPrime Create seamlessly integrates with existing document ecosystems, including regulatory information management (RIM) systems. This integration streamlines workflows by connecting critical tools and automating tasks like document version monitoring and first draft generation triggered by upstream document finalization.

Embracing the Future of Medical Writing

AuroraPrime Create's AI-driven capabilities transform clinical development documentation by:

• Boosting Efficiency: By automating time-consuming tasks, AuroraPrime Create significantly reduces document creation time, enabling faster submissions and potentially accelerating patient access to new treatments.

• Enhancing Quality: Built-in quality assurance mechanisms, including the use of "golden datasets" as benchmarks, help ensure accuracy, consistency, and compliance with regulatory standards.

• Empowering Medical Writers: By taking over routine tasks, AuroraPrime Create frees up medical writers to focus on more complex and strategic work, allowing them to expand their skills and deepen their knowledge of regulatory guidelines.

AuroraPrime Create is not just a tool but a strategic partner in navigating the complexities of clinical development documentation. It empowers biopharma companies and CROs to embrace the future of medical writing, where efficiency and quality go hand in hand.