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Transformation in TrialsAuthor: Sam Parnell & Ivanna Rosendal
A podcast about the transformations in clinical trial. As life science companies are pressured to deliver novel drugs faster, data, processes, applications, roles and change itself is changing. We speak to people in the industry that experience these transformations up close and make sense of how the pressure can become a catalyst for transformation. Language: en-gb Genres: Business, Entrepreneurship, Life Sciences, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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Audit Trails, RBQM, And Agentic AI Explained
Episode 9
Wednesday, 11 February, 2026
Send a textEver 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 RosendalJoin the conversation on our LinkedIn page
