Audit Trails, RBQM, And Agentic AI Explained

About this episode

The episode explores the importance of audit trails in clinical trials and the shift towards continuous data analysis in RBQM.

Send us Fan Mail 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...

People in this episode

Host: Ivanna Rosendal

Guests: Ellis Hiroki, Nechama Katan

Topics covered

• audit trails
• RBQM
• clinical trials
• data analysis
• eConsent
• ePRO

Keywords

• audit trails
• RBQM
• clinical trials
• data analysis
• eConsent
• ePRO
• E6(R3)
• siteroAI
• Wicked Problem Wizard

Mentioned in this episode

Organizations: Study OS, siteroAI, Wicked Problem Wizard, E6(R3)

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