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Mike Hutton

Mike Hutton

Mike Hutton, PhD, Director of Strategic Partnerships and Commercialisation at Almac Clinical Technologies, a clinical trial technology expert and SCRS Talks podcast guest.

Sep 28, 2026

3:36
So maybe can you help expand upon that and walk us through that difference? And most importantly, I think why it matters for how we design and plan our studies.
3:46
Absolutely.
3:47
I think protocol complexity and operational complexity, they always get grouped together, but they're really not the same thing.
3:52
As an academic protocol complexity, that really reflects the scientific design of the study.
3:57
And it can involve many complex eligibility criteria, intricate visit schedules, specialized assessments, and a really adaptive randomization of study designs.
4:07
And in my time in the industry, I have just seen that complexity has massively increased over time to the point today where I think protocols are both increasing complexity and constantly changing during the course of the study.
4:21
But it's operational complexity.
8:56
Mike, if you could, as we begin to wrap up, change one assumption that sponsor teams commonly make during study planning, talk to me about what that might be and what would you want them to maybe ask sites instead of that assumption? I think the assumption I challenge is that

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