ACT Brief: Cloud-Native Imaging Infrastructure, Community Relationships in Trial Design, and FDA Leadership Transition

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

• In a new ACT contributed article, sponsors are re-evaluating imaging infrastructure models as trials grow more complex and globally distributed. A structured cost model comparing on-premise, cloud DIY, and cloud-native platforms across a 20-site, 60-patient trial shows cloud-native deployments reduce total cost of ownership by approximately 81 percent and compress deployment timelines by 75 days, translating to over $4 million in avoided delay costs before accounting for quality improvements and staffing reductions.
• In part three of his video interview, Del Smith, PhD, CEO and co-founder of Acclinate, explained how deep community relationships generate insights that improve protocol design, endpoint selection, and site placement, while building an on-ramp that compounds in value across future studies and strengthens sponsor-community partnerships.
• Following yesterday’s initial reports, Marty Makary is no longer serving as FDA Commissioner, according to Politico, with HHS Secretary Robert F. Kennedy reportedly making the decision to remove him. The departure continues significant leadership turnover across federal health agencies, including multiple transitions at CDER and recent departures at CDC and CBER.

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