Generative AI: Optimizing Writing for Better Performance

The recent rise of generative artificial intelligence has driven change across drug development and regulatory processes. An article published in the journal Applied Clinical Trials details how AI is now able to accelerate clinical documentation, regulatory submissions and content generation. 

For the pharmaceutical industry to fully benefit from generative AI in automating clinical study reports (CSRs), it must optimize its writing approach,” said one of the paper’s authors, John April, senior director of adaptive content strategy at Eli Lilly and Company. “Eliminating subjectivity from CSRs and repetition between its text and tables can truncate review cycles. Without such optimization, generative AI will do little more than mimic how we’ve always written, saving only a modest amount of time. With optimization, we can not only accelerate document development but also better meet regulatory agency needs.”

For organizations to fully leverage generative AI-driven automation, they must first ensure that their content ecosystems are optimized for this technology. This involves data readiness, content readiness, aligning documentation processes with regulatory requirements and designing a content ecosystem in which each document serves a unique purpose.

Read the paper to learn more, and learn more about ASG, where we’re brainstorming ideas for research projects that explore the use of AI in medical devices. Contact us to explore the possibilities.