In Part 3 of this three-part conversation, Liam and Ted wrap up their discussion with Robert Goldman, Vice President and Global Head of Clinical Operations at Contraline, on a question that lands in every ClinOps inbox: is “AI-powered” innovation or marketing? Robert explains why a dashboard from eight years ago isn’t new just because it has an AI label, how to test a vendor’s pitch, and why AI should support clinical judgment, not replace it. He also asks the question he puts to every AI vendor: if the hours saved are real, why aren’t drugs reaching patients faster?

It’s the same demand for evidence Robert brings to feasibility estimates and site selection in Parts 1 and 2 of the series. Listen to all parts of the conversation to see how it runs from the first plan to the latest technology.

In Part 2 of this three-part conversation, Liam and Ted continue their discussion with Robert Goldman, Vice President and Global Head of Clinical Operations at Contraline, to talk about why feasibility so often fails to predict what happens next.

Robert explains why historical benchmarks mean little for a study that has never been done, and what he would use instead: measurable assumptions, early performance indicators, and intervention points agreed in advance. Ted raises the feasibility question he has never seen on a questionnaire, and Robert explains why sites are afraid to answer it honestly. They discuss why sponsors budget for backup sites, why the fastest responders aren’t always the best, and how sponsors can build real relationships with sites before the selection process begins.

Join us in Part 3 of the conversation as Robert gives his take on AI in clinical operations.

In Part 1 of this three-part conversation, Liam and Ted sit down with Robert Goldman, Vice President and Global Head of Clinical Operations at Contraline, who brings nearly 20 years of clinical research experience spanning CRO roles and sponsor-side clinical operations, to talk about why the industry rewards optimism in planning and demands realism in execution.

Robert shares how a detour through Caribbean medical school led him into clinical research by accident, and what he has learned about how lean biotech teams succeed: knowing what to build, what to outsource, and what good looks like. Together they look at why feasibility estimates stay unrealistic when everyone is incentivized to present the best case, and why optimism is not an enrollment plan.

Robert leaves listeners with the question he would ask instead of “how many patients can you enroll?”: show me the evidence for your estimate, and tell me what happens when you’re wrong.

In Part 3 of this three-part conversation, Liam and Ted wrap up their discussion with Duncan, President at DTS Language Services about AI, risk mitigation, and the human factors that are hard to capture in clinical trial translation.

Duncan calls translation the “last mile” of clinical trials, where small details can decide whether a site activates or a patient stays in a study. He explains why AI has a place when millions of words are on tight timelines, but argues that low-volume, high-risk clinical content is a very different proposition. He compares AI translation to an autopilot where the human is only brought in after something goes wrong, and describes how translators are spending 80% to 90% of the usual effort correcting AI output while being asked to accept much lower prices.

And just when it gets serious, Duncan closes with a story about what happened when he translated a stack of Chinese tattoos. Spoiler: most of it was gibberish!

In Part 2 of this three-part conversation, Liam and Ted continue their discussion with Duncan, President at DTS Language Services about patient trust, consistency, and the operational realities of translating clinical trial content.

Duncan explains how small issues, from inconsistent terminology to differences in date formats, can undermine a patient’s confidence in a study and even lead to missed visits. Trust comes from consistency, fewer handoffs, and an approach that fits the purpose of the content, and describes the “quilt factor” that builds up when previous translations, multiple CROs, and competing terminology databases pile on top of each other.

The conversation ends on a question every sponsor should ask before translation begins: what does success actually look like?

In Part 1 of this three-part conversation, Liam and Ted sit down with Duncan, President at DTS Language Services, to talk about the good, the bad, and the ugly of clinical trial translation. Drawing on experience in both pharmaceutical and language services, Duncan explains why translation is far more than converting words from one language to another, and why a mistranslation in a clinical study isn’t just a typo but a potential risk to a patient, a trial, or a regulatory submission.

Duncan explains why the real work of translation starts before the translation itself: understanding who is reading the content, their language, reading level, context, fears, and emotions, and making sure the final version is both linguistically trusted and faithful to the approved source. He argues that translators have to resist the temptation to “improve” content. Liam connects this to a problem he's seen: the constant addition of complexity, particularly in consent forms.

This episode is a candid look at the hidden complexity behind clinical trial translation and the role it plays in patient trust, compliance, and study execution.

In this episode, Ted introduces the “ENROLL Corporation” (Everyone Needed for Recruitment Optimization Leadership and Logistics) an imaginary joint venture owned by the sponsor, the CRO, every site, and every vendor. He explains why most recruitment providers solve one small piece of the problem, much like a wildlife photographer so focused through a 500mm lens that an animal wanders past unnoticed.

Liam adds a river analogy about who “eats their own cooking,” and together they look at the 80-plus factors that affect recruitment, the holes in the enrollment funnel that nobody measures, and how adding complexity to a protocol can quietly cost months.

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 conflict when the same experienced DMC member sits on multiple competing trials
What a safety oversight committee looks like when it’s “firing on all cylinders."

Robin also digs into a problem many sponsors don’t see coming: experienced DMC members who sit on multiple competing trials and intelligence bias the conflicts this creates.

This is the practical half of the conversation, moving from why to how, with guidance on getting your safety oversight set up and ready before an inspector asks to see it.