Lower amendment risk across clinical trials with AI

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.

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.

Speakers

Paolo Martini, Chief Research Development Officer, ReAlta Life Sciences

With more than 20 years of experience in drug development, Paolo Martini, PhD, brings deep, firsthand insight into the challenges this webinar will explore. He founded Moderna’s Rare Diseases division and led multiple programs through early development and pre-IND filing at Shire HGT (now Takeda). Throughout his career, he has managed the operational realities of precision medicine trials, including complex eligibility criteria and rigorous safety monitoring requirements.

Most recently, as Chief Research & Development Officer at ReAlta Life Sciences, Paolo led drug discovery efforts from concept through proof-of-concept, focusing on rare diseases and hematologic malignancies.

Across these roles, Paolo has learned, often the hard way, which trial designs may appear scientifically sound but prove difficult to execute in practice. Paolo holds a PhD in Molecular Biology from the University of Milano and completed postdoctoral training at the University of Milano and the University of Illinois Urbana-Champaign.

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Pedro Coelho, Founder & CEO, Biorce

Pedro Coelho founded Biorce in 2024 after years of watching pharmaceutical companies repeat the same design mistakes, at scale, at cost and at the expense of patients waiting for treatments.

As a Strategy Consultant advising pharma and biotech (including creating TMFS, a CRO focused on oncology and cell/gene therapy at Talentmark), Pedro saw the pattern: experienced teams making decisions based on 50-100 trials they had personally seen, unaware they were missing critical patterns visible only across hundreds of thousands of clinical protocols.

Biorce’s platform now analyzes ~1M clinical trials to surface those patterns, helping teams make better upstream decisions.

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