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In today’s ACT Brief, we examine how AI is moving into continuous clinical operating models, how trust is built into oncology real-world evidence, and how the FDA approved a self-administered option for thyroid eye disease.

Paradigm’s Kurt Mussina discusses why scale should drive operational efficiency, not consolidation into single-site studies.

Paradigm’s Kurt Mussina touches on why he rejects the “site management organization” model in favor of one unified business.

ProofPilot’s Lauren Briggs talks on why sponsors and CROs fail at tech rollouts by skipping change management, and pushes for the industry to judge trial technology by real workflow impact rather than feature checklists.

ProofPilot’s Lauren Briggs touches on why site tech adoption hinges on the first 90 days after rollout, and why tools succeed only when they remove work from a site’s plate rather than adding another login to juggle.

Jennifer Byrne, CEO, Javara touches on why fixing clinical research requires sustained infrastructure investment and workforce development.

Sequoia’s Dan White and Dr. Tom Kreamer touch on why sponsors and CROs should treat a site network as one centralized partnerto speed startup timelines and strengthen execution.

Sequoia Clinical Research’s CEO Dan White and CMO, Dr. Tom Kreamer explain what it takes to merge three site organizations into one network.

Javara CEO Jennifer Byrne talks about the requirements for embedding clinical trials directly into physician practices and why solving the “last mile” of trial participation means building infrastructure at the actual point of care.

Trially Co-founder and CEO Kyle McAllister, explains how AI absorbing the bulk of clinical-trial chart reviews can free research sites to focus staff time on higher-value tasks.

In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, explains why the shift from narrow AI tools to a continuous learning clinical operating system is where the real operational value lies—and what it takes to get there.

In this Q&A, Saamir Pasha and Carole Berini, PhD, of Ontada discuss what it takes to harmonize fragmented oncology data into reliable real-world evidence, how lab markers can proxy for missing functional status data, and where the biggest remaining barriers to consistent RWE generation lie.

In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an immunotherapy to a new bladder cancer population.