ACT Brief: Community Sites Compete on Readiness, COA Licensing Bottlenecks Slow Start-Up, and AI’s Foundations in Pharmacovigilance

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In part three of an Applied Clinical Trials interview, Liz Beatty of Inato said community research sites continue to face barriers as sponsors rely on a small subset of familiar sites to run most trials. Beatty noted that growing pipeline competition at large academic centers is creating new openings, and said community sites that invest in AI and can credibly demonstrate real-time patient access—especially in underrepresented populations—are better positioned to secure trial opportunities in 2026.
• In a new contributor article, Florence Mowlem, PhD, highlights how delays in licensing and translating clinical outcome assessment measures continue to slow clinical trial set-up and put first patient in at risk. The article argues that limited pre-license access to COAs, unclear copyright ownership, and inconsistent response timelines force sponsors and eCOA providers to “buy blind,” and calls for earlier access to official measures to streamline protocol development, electronic implementation, and trial start-up.
• In a 2026 industry outlook interview from our sister publication, Pharm Tech, Beena Wood of Qinecsa said AI has the potential to transform pharmacovigilance through near–real-time global safety surveillance, but only if foundational issues are addressed first. Wood pointed to fragmented, non-standardized data, lack of interoperability, and unresolved trust and explainability concerns as key barriers, adding that organizations investing now in data foundations, governance, and change management will be best positioned to scale AI responsibly.

That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.