Transformation in Trials

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What happens when we stop calling people “subjects” and start inviting them to help build the solutions they need? We sit down with pharmacist and patient engagement leader Mark Duman to unpack how language, literacy, and lived experience can transform clinical trials, medtech, and digital health from the ground up. Mark introduces his three Cs—co-creation, choice, and coaching—and shows how each one moves care from doing to people toward working with and learning from them.

We dig into the hidden pitfalls of relying solely on patient advocacy groups, why representation matters, and how to reach the millions who never join a mailing list but live with the biggest burdens. Mark shares a practical bridge: “staff as patients,” an internal, compliant way for organisations to hear real stories and test assumptions. From there, we explore informed consent that genuinely informs, outcomes data people can understand, and the right to know who is treating you and how good they are—without drowning in jargon.

The conversation then zooms out to health literacy and data literacy as core citizenship skills. Wearables, home testing, and portals promise insight, but only if people can interpret trends, risk, and uncertainty. We talk about building inclusive paths for both digital-first and low-tech preferences, making space for community-driven solutions. Parents in rare diseases show what’s possible when lived experience meets scientific rigour: they convene experts, shape protocols, and even spark new therapies. That is the “meeting of experts” mindset—clinical knowledge and daily life experience on equal footing.

Finally, we take on prevention and incentives. Can industry support prevention without fearing cannibalisation? Some already do, and the smarter lens treats trust and long-term health impact as strategic assets. We close with concrete steps any team can take: map patient journeys, test language for clarity, co-design eConsent, reduce protocol burden, compensate fairly, and measure how patient input changes recruitment and retention. Subscribe, share with a colleague who designs studies or products, and leave a review telling us one phrase you’ll stop using and what you’ll say instead.
Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.
Getting treatment to patients faster requires well-functioning organizations. How do we do that? Ivanna Rosendal has written a book called Maneuvering Monday, about how a group of people try to make their organization better. You are certain to have a good laugh at their expense. And potentially get inspired how you can help make your company better.
I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce.
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Ever wondered why a clean CSR still leaves you unsure how a trial actually ran? We dive into the hidden layer that explains the “how”: audit trails across EDC, IRT, eConsent, and ePRO. With guests Ellis Hiroki of Study OS (now rebranded  siteroAI) and Nechama Katan of Wicked Problem Wizard, we unpack how E6(R3) shifts sponsors from “we can export logs” to “we continuously analyse them,” and why process measures—not just outcomes—are essential to real RBQM.

We break down the obstacles that keep teams stuck in CSV purgatory: fragmented vendor data, missing standards, timestamp chaos, and brittle one-off scripts. Nachama shares pragmatic use cases that matter—like ePRO entries after discontinuation or suspicious mass updates—and how to prioritise by likelihood, detectability, and severity. Ellis explains why general AI isn’t enough, and how a purpose-built, agentic approach uses models to plan steps and generate validated SQL or code, rather than hallucinated answers. The result is auditable reasoning, repeatable checks, and faster paths from a clear question to a trusted signal.

From there, we connect signals to action. Analytics without workflow creates noise; analytics with RBQM workflows produce root causes and durable fixes. We explore how audit logs become the first true process dataset in clinical operations, and how broader operational inputs—logistics, communications, and training—can also be measured when systems are API-first and integrated. If you’ve ever watched a leadership question trigger a scramble in stats programming, this conversation shows a cleaner route: experts ask in plain English, the system produces valid code and dashboards, and teams focus on insight rather than plumbing.

If this resonates, follow the show, share it with a colleague, and leave a review. Your feedback helps us bring more practical, high-signal conversations to the clinical trials community.
Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.
Getting treatment to patients faster requires well-functioning organizations. How do we do that? Ivanna Rosendal has written a book called Maneuvering Monday, about how a group of people try to make their organization better. You are certain to have a good laugh at their expense. And potentially get inspired how you can help make your company better.
I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce.
Join the show as a guest - apply via this Form.
Support the show

________
Reach out to Ivanna Rosendal

Join the conversation on our LinkedIn page

Send a text
Want clinical research that respects real life? We sit down with Caroline Potts, GM of Site and Patient Services at MRN, to rethink how patients are recruited and supported when the standard trial model collides with work, school, caregiving, and distance. We start at the site level, exploring why trial sites remain the beating heart of studies, then unpack how participants actually arrive: investigator databases, advocacy networks, disease-specific portals, and focused social campaigns that reach people where they already are.

From there, we tackle the hidden friction in protocols. Do you really need a physical exam at every visit, or can a trained nurse complete most procedures at home, at work, or even at a holiday address? Caroline gets specific about what’s possible outside the clinic—centrifuges, compliant drug delivery, courier timing—and where the red lines remain, like imaging. The conversation separates hype from substance on decentralised trials, arguing that the true shift is operational flexibility, not just apps. We also assess AI’s promise in finding eligible patients while calling for rigorous validation and thoughtful use alongside human support.

The heart of the episode is practical patient centricity. We discuss rare diseases and long travel times, evening and weekend scheduling, reimbursement barriers, and how small design choices can either invite people in or push them away. Participants commit years of their lives to studies; the least we can do is meet them halfway. Caroline closes with a bold wish: compress timelines across the entire development arc. Precision medicine has moved forward; trial operations must catch up.

If this resonates, follow the show, share it with a colleague, and leave a review to help more listeners find thoughtful conversations on modern clinical research.
Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.
I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce.
Join the show as a guest - apply via this Form.
Support the show

________
Reach out to Ivanna Rosendal

Join the conversation on our LinkedIn page

Send a text
Two leaders from Sionna Therapeutics walk through a 15‑year journey from Genzyme science to a public company advancing NBD1‑targeted therapies in cystic fibrosis. We examine why most patients still fall short of normal CFTR, how a predictive assay de‑risks choices, and what it takes to finance, hire, and execute with patients as the North Star.

Visit: sionnatx.com

Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.
Getting treatment to patients faster requires well-functioning organizations. How do we do that? Ivanna Rosendal has written a book called Maneuvering Monday, about how a group of people try to make their organization better. You are certain to have a good laugh at their expense. And potentially get inspired how you can help make your company better.
I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce.
Join the show as a guest - apply via this Form.
Support the show

________
Reach out to Ivanna Rosendal

Join the conversation on our LinkedIn page

Send a text
What if the documents behind a clinical trial were written with the patient’s voice in mind and delivered at the speed modern science deserves? We sit down with writer, consultant, and patient-advocate Bilal Bham to unpack how protocols, clinical trial applications, and clinical study reports actually get made, why structure beats chaos, and where AI genuinely shortens timelines without cutting corners. From first protocol outlines to final submissions, Bilal shares a process that blends proprietary AI with rigorous human review to turn dense source data into clear, regulator-ready narratives.

The conversation gets real about the craft. Bilal argues that new writers still need to learn documents end-to-end: where to find truth in source files, how to build arguments across sections, and how to keep stakeholders aligned from biostats to clinical operations. AI helps when you feed it the right ingredients, starting with comprehensive bullet-pointed outlines rather than instant prose. That discipline shaves weeks off delivery and keeps quality high, especially when regulators are exploring AI on their side of the table and expect traceability, accuracy, and transparent logic.

We also explore the power of inclusion. Living with Graves’ disease and thyroid eye disease, Bilal explains how patient experience sharpens trial design, consent language, and symptom reporting. Diversity is not a banner; it is better science. Recruiting across local communities in the UK, US, and Europe strengthens external validity and reveals gene-environment differences that change safety and efficacy. Pair that with plain-English patient summaries, fair compensation, and trusted community partners, and you get trials that are faster to run, easier to understand, and more likely to help the people who need them most.

If you care about clinical trials, regulatory writing, medical communications, AI in pharma, and building inclusive studies that actually work in the real world, this conversation is for you. Subscribe, share with a colleague, and leave a review with your take: where should inclusion start in clinical research?
Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.
I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce.
Join the show as a guest - apply via this Form.
Support the show

________
Reach out to Ivanna Rosendal

Join the conversation on our LinkedIn page