TOPIC: From Manual to Three Clicks: AI in Clinical Trials
TOPIC DESCRIPTION: Clinical trials generate vast amounts of data, and transforming this data into reliable statistical outputs for regulatory submissions has traditionally been a slow, manual, and error-prone process. Statistical programmers often spend weeks coding, re-checking, and validating tables, listings, and figures (TLFs), with significant resources required to ensure compliance with FDA/EMA standards. TriClickT was built to change this paradigm. Powered by agentic AI, TriClick automates statistical programming and delivers analysis-ready outputs with just three simple clicks. By embedding regulatory knowledge into its core, TriClick not only accelerates the delivery of TLFs but also ensures traceability, auditability, and compliance at every step. In this session, we will: Demystify AI in clinical trials - explaining how automation works in statistical programming without requiring teams to become AI experts. Showcase real-world applications - how leading pharmaceutical companies are already using TriClick to accelerate submission timelines and reduce programming errors. Highlight regulatory alignment - demonstrating how TriClick ensures outputs meet industry standards (CDISC, 21 CFR Part 11) and builds confidence for both sponsors and regulators. Explore efficiency gains - from manual coding that takes weeks to automated processes completed in hours, freeing statisticians to focus on higher-value analyses. Attendees will leave with a clear understanding of how AI is no longer a futuristic concept but a practical tool ready to support today's biostatistics teams. Whether you are a statistician, clinical data professional, or regulatory affairs specialist, this session will provide actionable insights into how TriClick can simplify workflows, reduce costs, and ultimately accelerate the path from data to decision. By bridging human expertise with AI-driven automation, TriClickT represents a new standard: transforming the clinical trial process from manual to three clicks.
SPEAKER: Alexandre Duprey
SPEAKER BIOGRAPHY: Dr. Alexandre Duprey is an entrepreneurial mathematician and biostatistician with over a decade of experience in clinical trial design and analysis. After research at Yale School of Medicine, he advanced to lead biostatistics at New Jersey Stats, supporting breakthrough FDA submissions and innovative trial simulations. He later served as Senior Consultant at Flagship Pioneering before founding Hill Research, where as Chief Scientific Officer he built biometrics and quality teams and pioneered AI-driven automation of clinical trials. Beyond his professional role, he is also a world-recognized board game strategist and mentor.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied towards re-certification/ continuing education from the following organizations:
| 1.5 pts |
RAC recertification from RAPS |
| 1.5 CEUs |
CCRP recertification from SOCRA |
| 1.5 CEUs |
CIP recertification from PRIM&R |
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This webinar will be recorded.