What happens when clinical trial technology works exactly as requested—but makes the study worse? Jason Spivey, founder of Unifora, joins Steve to unpack the operational mistakes that can turn promising technology into expensive problems, from overwhelming participants with notifications to testing site workflows without anyone who understands how sites actually work.

They also discuss why sponsors, CROs, sites, and vendors struggle to align their incentives, how technology gets purchased without enough scrutiny, and why some integrations consume months of work without solving a real problem. Plus: carbon-copy paper belongs in a museum, Jason's enthusiasm for haunted attractions, and how much he'd pay to escape a particularly unfortunate chair-related curse.

00:00

Meet Jason Spivey & Unifora

04:48

Do Sponsors, Sites & Vendors Really Share the Same Goals?

08:02

Why Collaboration Breaks Down

10:13

The Clinical Research Museum

11:23

Haunted Houses & Halloween Horror

12:51

The $1 Million Chair-Fart Curse

14:10

When Technology Works but the Experience Fails

16:32

Who Owns a Bad Technology Decision?

18:06

The Problem With User Acceptance Testing

20:38

Are We Getting Better at Choosing Technology?

22:53

The Mistakes Sponsors Keep Repeating

26:11

How Jason Uses AI

29:25

When Technology Was the Wrong Purchase

32:51

When to Cut Your Losses

34:47

Closing & Where to Find Jason

What happens when an IRB's responsibility to protect research participants runs into the commercial realities of clinical research? Mike Keens, CEO of Sabai, joins Steve to discuss whether IRBs should flag protocols that are technically acceptable but unreasonable for patients, why certain private equity ownership structures raise difficult questions about independence, and what the industry gets wrong about IRB turnaround times. They also explore how an oversight organization can build a business around telling customers “no,” why Mike uses AI to challenge his own thinking, and whether the best regulatory response might actually be “no, but…”

Plus: Paul Simon, outlawing terrible meeting phrases, and a surprisingly consequential decision about finger guns.

00:00

Meet Mike Keens & Sabai

02:33

Should IRBs Judge Participant Burden?

06:15

AI as a Critical-Thinking Partner

09:28

Paul Simon & Setting Expectations

10:28

One Phrase Mike Would Ban From Research Meetings

12:20

Finger Guns, Bows or Salutes?

13:48

Private Equity & IRB Independence

18:40

When Is a Financial Conflict Too Close?

21:00

What People Get Wrong About IRBs

23:41

Are IRBs Just Rubber Stamps?

25:19

How Do You Build a Business Around Saying No?

28:15

Where to Find Mike & Sabai

Independent research sites are expected to move quickly, adopt new technology, train constantly, recruit successfully—and somehow absorb a lot of the work required to make all of that happen. Alexandria Hull, co-founder and CEO of One of a Kind Clinical Research Center, joins Steve to talk about where small sites have an advantage, what sponsors routinely underestimate in study budgets, and why a site's “yes” doesn't always mean a study is truly feasible. They also get into technology that only works for people who love technology, who's responsible for excessive training, and why sometimes the most productive thing a site can give a sponsor is a very blunt warning.

Plus: AI's dash problem, Harry Potter science, and an alarmingly serious analysis of whether it's preferable to fight a bird every day or be attacked with water by a random child.

00:00 — Meet Alexandria Hull & One of a Kind Clinical Research Center
02:43 — Harry Potter, But Make It Science
03:35 — Where Independent Sites Have an Advantage
05:45 — When Does Staying Independent Stop Making Sense?
07:23 — AI, Hyphens & the Blank-Page Problem
10:31 — How Much Can Better Technology Actually Improve a Site?
14:15 — Fight a Bird or Get Soaked by a Child?
15:56 — What Sponsors Underestimate in Study Budgets
19:09 — When Budget Teams Don't Understand the Work
23:11 — The Side Effects of Running a Clinical Trial
24:22 — When Should a Site Say No to a Study?
27:26 — Are Sites Part of the Technology & Training Problem?