mRNA Clinical Trials: Regulatory Considerations

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.