What makes a clinical trial site successful when managing complex transplant studies? In this episode of “Moving Medicine Forward,” host Jeremy Schrand is joined by Shawna Bredek, a 20+ year veteran in clinical trial operations, to explore how feasibility assessments shape the future of life-saving research. Shawna shares how her team evaluates sites, navigates post-COVID challenges, tackles regulatory hurdles, and builds lasting relationships that help bring rare disease treatments and transplant innovations to life. Whether you're working in clinical research or simply curious about medical breakthroughs, this episode offers a compelling look at the strategy behind meaningful science.
Show Notes:
00:36 Meet Shawna Bredeck, VP Global Site Activation & Clinical Document Management at CTI
00:52 Feasibility in the context of a clinical trial
01:18 Why choosing the right site and Private Investigator is critical
02:12 Post-COVID challenges: site fatigue, turnover, and timelines
03:34 Sponsors’ expectations vs. site realities
04:03 Asking tough feasibility questions upfront
05:17 Transplant-specific logistics: 24/7 coverage and site readiness
05:54 Navigating regulatory red tape across countries
07:28 How regulatory delays can stall important trials
08:12 Global differences: why it’s easier to start in Brazil than the US
08:54 Engaging rare disease sites through relationships and reputation
09:56 Partnering with advocacy groups for trial success
10:58 Shawna’s proudest career moment: a major transplant drug approval
12:21 The human side of transplant research
12:50 The shared mission of patients, sponsors, sites, and scientists
13:02 Final thoughts and how to connect with CTI
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