The Leukemia & Lymphoma Society (LLS) and Narrativa, the preeminent AI company serving the life sciences industry, have strengthened their partnership to further improve the clinical trial documentation processes. Building on their previous collaboration, the two organizations are now focused on improving the accuracy and efficiency of Patient Narratives, TLFs (tables, listings and figures), and CSRs (clinical study reports) for The Leukemia & Lymphoma Society Beat AML® (BAML) studies using Narrativa’s proprietary Generative AI platform.

In this new phase of their partnership, Narrativa will fully automate the generation of Patient Narratives, TLFs and CSRs for the BAML clinical studies, allowing for the creation of multiple drafts before study completion. Additionally, BAML’s Medical Writing team will receive extensive training on Narrativa’s platform, equipping them with the necessary tools to validate and refine AI-generated regulatory documentation in real-time, notably before the final database lock of each trial. By enabling earlier access to clean, high-quality data, this approach not only enhances document accuracy but also significantly reduces timelines, ensuring that regulatory submissions are completed more efficiently and with greater confidence. The project aims to establish a structured and automated approach for regulatory documentation generation, streamlining the regulatory writing process for both current and future studies.

Our platform enables seamless extraction and summarization of information from tables, making complex data more accessible and actionable.

Transforming Clinical Trial Regulatory Documentation Through AI 

The integration of AI-driven automation into clinical trial regulatory processes is expected to:

• Improve data accuracy and consistency by standardizing regulatory documentation configurations and data mapping;
• Enable rapid quality assurance testing and validation of the AI-generated regulatory documentation prior to study completion;
• Reduce the time and resources required for regulatory reporting, accelerating the approval process for potential new treatments.

“We are thrilled to expand our collaboration with LLS after the success of our previous projects. This partnership continues to demonstrate how AI can transform regulatory documentation, improving both efficiency and accuracy. Most importantly, by accelerating these processes, we are increasing the AI confidence level for medical writers utilizing these new tools and ultimately helping to save more lives,” said Jennifer Bittinger, President of Narrativa.

“Over the past two years, our BAML team has come to truly value Narrativa’s AI solutions for multiple regulatory documentation needs. By rapidly generating full first drafts of complex documents, these tools not only free up our medical writing team to focus on higher-value tasks but also expedite the data cleaning process, ensuring that high-quality, reliable data is available earlier. Generating TLFs, CSRs, and Patient Narratives before database lock allows us to identify inconsistencies and refine data with a level of speed and accuracy that traditional methods or CRO reviews might miss in such a short timeframe,” said Ashley Yocum, Ph.D., Executive Research Strategy Lead, Beat AML Master Trial, The Leukemia & Lymphoma Society.

As Narrativa and The Leukemia & Lymphoma Society move forward with this initiative, they remain committed to revolutionizing clinical trial regulatory documentation, setting new standards for AI-driven medical writing, and ultimately expediting the path to life-saving treatments.

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society® (LLS) is the global leader in the fight against blood cancer. The LLS mission: Cure blood cancer and improve the quality of life of all patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.

Founded in 1949, LLS has regions throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.

For additional information, visit lls.org/lls-newsnetwork. Follow on Facebook, Twitter, and Instagram.