Episode 24: Getting IRT Right - Craig Mooney, Founder & Principal Consultant at IRT Advisors Group

In this warm, nostalgic conversation, Craig Mooney, Founder of IRT Advisors Group, reunites with Patty, a colleague from their earliest days in clinical research, to reflect on a career spent in what he calls “a niche of a niche of a niche.” What began as a summer job, and nearly a career as a history teacher, became three decades of expertise in interactive response technology across a pioneering startup, a clinical supply organization, big pharma, and vendors around the world. 

You’ll hear Craig and Patty explore how IRT quietly transformed the way studies are designed and run, why moving from vendor to sponsor offers an eye-opening perspective, and how a regulatory inspection sparked a push for higher standards across the industry. They also discuss taking entrepreneurial risks, the value of international experience, and where AI fits into a field that still depends on deep subject matter expertise. This episode explores how a commitment to quality and a willingness to share knowledge can raise the bar for an entire industry. 

What you’ll hear about 

• Why can getting IRT wrong have such devastating consequences for trials? 

• How did interactive response technology change the way studies are designed? 

• What do you learn when you move from vendor to sponsor? 

• How are regulators raising expectations for IRT systems and data? 

• Can a career setback actually set you up for success? 

• Where does AI fit when deep expertise still matters most? 

This episode is intended for clinical supply and IRT leaders, offering a clear perspective on building compliant, scalable IRT strategies that stand up to regulatory scrutiny. 

Timestamps 

00:10 – Launching IRT Advisors Group 

01:00 – Early days at Besselaar 

04:35 – Stumbling into the world of IRT 

06:50 – How IRT changed clinical trial design 

08:20 – Seeding an industry 

11:10 – Seeing the supply chain side at Fisher 

13:25 – The setback that became a setup 

16:40 – Crossing over from vendor to sponsor 

17:45 – The inspection that changed everything 

20:05 – Spreading the word across the industry 

21:05 – Why sharing knowledge matters 

25:35 – Lessons from working abroad 

28:10 – Why start IRT Advisors Group 

32:50 – AI, inclusion, and the state of the industry 

35:05 – Why AI can’t fix a broken foundation 

Guest Biography 

Craig Mooney is the Founder of IRT Advisors Group, where he helps sponsors build strategic, scalable approaches to interactive response technology and supports organizations evaluating the IRT landscape. With roots at pioneering CRO Besselaar Associates, he has spent three decades in IRT across an early technology startup, Fisher, Bristol Myers Squibb, and global vendor organizations. A passionate advocate for quality and industry-wide learning, Craig is committed to raising the bar for how IRT supports patients and clinical research.