Sponsored Webcast: Scaling Accessible CTIS with Governed AI (On Demand)

As CTIS implementation advances and expectations for plain language summary (PLS) continue to evolve, regulatory teams are under increasing pressure to deliver accessible, high-quality content on tighter timelines and across multiple languages. Traditional, document centric workflows often introduce delays, inconsistencies, and rework—challenges that become more pronounced as transparency requirements expand. At the same time, both sponsors and regulators are shifting toward more iterative, real- time approaches to review and assessment.

This webinar explores a practical operating model for scaling PLS development using governed AI and Agile-informed workflows where AI agents orchestrate drafting, review, and revision tasks within defined governance controls. Attendees will learn how structured templates, source anchored drafting, readability targets, and human-in-the-loop quality control can be combined to reduce manual effort (reduce cycle times and rework) while maintaining clarity, traceability, and regulatory confidence. The session concludes with a live AgileWriter® demonstration showing how AI-enabled workflows facilitate iterative drafting, review, and localization of PLS content aligned with CTIS timelines and provide a scalable blueprint for modernizing PLS operations in an increasingly transparent regulatory environment.

Learning Objectives

Explain how evolving CTIS and PLS expectations are driving a shift toward more iterative, real time regulatory workflows
Identify common bottlenecks in manual PLS development and how governed AI can help address them
Apply practical, human in the loop approaches to improve consistency, accessibility, and review efficiency at scale

Who Should Attend?

Regulatory affairs professionals involved in clinical trial transparency and disclosures
Medical writers and publication professionals supporting plain language summaries
Clinical operations and transparency teams working with CTIS
Quality, governance, and digital transformation leaders evaluating AI enabled workflows

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.