Ep. 2.25 The Burdens Still Breaking Clinical Trials: 50-Page Consents, Broken Tech, and Stolen CRCs

In Part 2, Robin Piazza, Liam and Ted get specific about what good safety oversight actually looks like in practice, and what sponsors are getting wrong under the shift from FDA 2024 guidance to the stricter ICH E6 R3 standard. We explore: - FDA 2024 guidance vs. ICH E6 R3: why global studies need one uniform plan - Why a DMC charter is a “how the DMC will operate," not evidence, and is what inspectors actually want to see, and whether the charter was followed. - The hidden conf...

Robin Piazza reached out to us directly with this topic suggestion, and we’re glad she did. In Part 1 of this two-part conversation, Liam and Ted sit down with Robin, Founder of Sapiens GC, who spent over 20 years building and running the industry’s first commercial data monitoring committee service before going independent. She breaks down what a data safety monitoring committee actually does, where sponsors, CROs, and vendors each fall short, and why having one independent, unblinded party ...

In this episode, Liam and Ted ask a simple “what if”, what if the industry took the time to really listen? Ted starts with a study startup delay that looks like a tooling problem but turns out to be a relationship problem. While Liam shares what happened when he pulled a frontline team member into a leadership meeting and found a patient-flow blocker that had backed up a 120-patient-a-day site for days. They talk about why most trial meetings leave no room for problem-solving or relat...

Each episode in this series has built toward this one: what does all of this look like from the other side of the table? In the final part of this series, the Steve Wimmer shares his experince participating in several clinical trials himself, including one he screen-failed out of, and shares what that experience actually taught him about consent, communication, and being left in the dark. Liam and Ted add their own stories of trying to get into a trial as ordinary, motivated patients a...

Part 1 was about why storytelling matters, part 2 is about how to actually operationalize it and Steve Wimmer brings a framework that reframes the entire recruitment funnel. Every interaction a patient has, from the first ad to the first phone call, is either a trust deposit or a trust withdrawal. Miss that, and the best story in the world won't save a campaign that confuses people the moment they land on a website. Steve Wimmer, Liam Eves, and Ted Trafford move from why storytelling m...