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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.

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Hosts

Alexander Booth aka the MedTech Guy

Dimitri Borisevich aka the start-up Guy

Ivanna Rosendal aka the R&D pharma Gal