Audit Trails, RBQM, And Agentic AI Explained

Send us Fan MailEver 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.Visit Labtolives.com Do you want to try the quiz from this episode? Find the link on our LinkedIn profile: https://www.linkedin.com/company/labtolives/ Would you like to join the show as a guest or collaborator? Find out how on our website: https://www.labtolives.com/ Support the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander Booth aka the MedTech GuyDimitri Borisevich aka the start-up GuyIvanna Rosendal aka the R&D pharma Gal