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Clinical Trial Events
CDISC US Interchange 2026

Talk Main Conference CDISC track

Interrupting the Conversation: AI-Assisted Clinical Submission Artifacts as a Model for Targeted AI Adoption

Mon, Oct 5, 2026 · 4:30–5:00 PM MDT Evergreen B, Denver Marriott Tech Center

About this session

Part of Session 4, Track B: Submissions (Chair: Asif Karbhari, AstraZeneca).

Artificial intelligence is reshaping how organizations approach complex, rule-bound processes. While some functions are shifting rapidly, those with deeply embedded expertise often find AI results underwhelming or counterproductive. The problem is rarely capability, but rather that solutions tend to answer the wrong questions because experts are uncertain how to ask the right ones. It is not so much a failure to communicate as a timidity of imagination.
This paper presents two interconnected use cases. The first automates the generation of the SDTM-annotated Case Report Form. The second facilitates Define-XML generation. In both, a conversational AI platform serves as a Software as a Solution (SaaS) development partner, enabling rapid prototyping and a more creative approach to day-to-day challenges. The aim is not necessarily to displace enterprise solutions, but to demonstrate, through targeted and immediately practical examples, how domain experts can begin extracting real value from these tools today.

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