From Amendments to Optimization: How AI is Transforming Clinical Trial Design, Upcoming Webinar Hosted by Xtalks

In this free webinar, see why eligibility criteria modifications are the #1 cause of protocol amendments, and which criteria structures consistently trigger changes across therapeutic areas. The featured speakers will discuss the site selection factors that predict enrollment performance (beyond historical relationships and therapeutic area experience). Attendees will learn how to defend AI-assisted design decisions to regulators, with exact documentation requirements EMA/FDA demand. The speakers will also share insight into the real amendment cost beyond the $535,000 direct cost, including how 6+ weeks of frozen enrollment impacts trial timelines and budgets.

TORONTO, May 6, 2026 /PRNewswire/ -- Protocol teams can invest months in expert review and still face costly amendments, frozen enrollment and delayed Phase III timelines. This webinar explores how AI can help teams identify amendment risk earlier, evaluate design tradeoffs more effectively and strengthen protocol decisions before execution.

Research has shown that 57% of protocols undergo at least one substantial amendment and that 45% of those amendments may be avoidable (Getz et al., 2016). Warning signs often exist in the data, but they can be difficult to detect through experience alone. Patterns linked to amendment risk can emerge across eligibility criteria, site selection and endpoint choices, especially when large volumes of trial data are analyzed at scale.

This webinar examines how data-driven analysis can reveal which eligibility criteria are most likely to slow enrollment, which site factors are more predictive of performance and which design combinations are more likely to require amendments. The featured speakers will address how teams can apply AI-supported insights to support regulatory review and internal decision-making.

Attendees will leave with practical guidance on evaluating protocol design decisions, reducing avoidable amendment risk and improving enrollment planning across therapeutic areas.

Register for this webinar to learn how AI for clinical trials can reduce protocol amendments, improve enrollment planning and support more defensible trial design decisions.

Join Paolo Martini, Chief Research & Development Officer; Pedro Coelho, Founder & CEO, Biorce; and Bruno Gagnon, BPharm, MSc, Senior Vice President, Clinical Development & Operations, Spruce Biosciences, for the live webinar on Thursday, May 28, 2026, at 11am EST (5pm CEST/EU-Central).

For more information, or to register for this event, visit From Amendments to Optimization: How AI is Transforming Clinical Trial Design.

Getz KA, Stergiopoulos S, Short M, Surgeon L, Krauss R, Pretorius S, Desmond J, Dunn D. The Impact of Protocol Amendments on Clinical Trial Performance and Cost. Ther Innov Regul Sci. 2016 Jul;50(4):436-441. doi: 10.1177/2168479016632271. PMID: 30227022.

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