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About the webinar
The rapid expansion of artificial intelligence (AI) solutions is transforming the clinical trial landscape,
introducing both opportunities and significant challenges for regulatory professionals. Nowhere is this more evident
than in clinical trial disclosure and transparency, where evolving global regulations, heightened expectations for
participant communication, and the complexity of managing sensitive data have raised the bar for compliance and
efficiency. Sponsors face persistent hurdles, including inconsistent and sometimes unverifiable information from major
technology vendors, as well as the risk of errors or “hallucinations” from large language models —
issues that can undermine trust and complicate efforts to streamline manual processes and reduce disclosure cycle
times. The latest updates to Good Clinical Practice (GCP) guidelines and regional regulations further emphasize the
ethical imperative of transparency, plain-language communication, and scalable, participant-centered disclosure
practices.
In this session, Brian Kuzich and Jack Marks will share insights from Citeline’s experience supporting sponsors
through these challenges. They will discuss real-world questions regulatory teams are asking, the evolving strategies
within Citeline’s regulatory business unit, and how a human-in-the-loop-centered AI approach is shaping product
design and operational roadmaps to meet the demands of modern disclosure and transparency.
Learning Objectives
- Understand the impact of AI on clinical trial disclosure and transparency
- Identify key regulatory hurdles sponsors face when integrating AI
- Examine real-world strategies and use cases for implementation
- Understand the benefits and value of a human-centered approach
