The session covers three things practitioners can apply immediately: how to start with the risk rather than the data (Decisive Focus); what it takes to get audit trail data into a state where it can actually be analyzed, and what analytical maturity really looks like beyond descriptive statistics (Grounded Intelligence); and how to replace the spreadsheet-and-email-chain workflow with something integrated and proactive (Frictionless Execution).

Attendees will leave with a clear picture of where their organization sits on the ATRA maturity model, what good looks like at each level, and what the next concrete step is. Whether your team is just getting started or trying to scale what already exists, this session gives you the framework to stop firefighting and start building something defensible.

MEET THE PRESENTER

Nechama Katan is the founder of Wicked Problem Wizards and works on risk-based quality management, audit trail analytics, and AI validation in clinical trials.

She co-led the eClinical Forum working group that produced the Audit Trail Review Analytics industry position paper, downloaded over 2,400 times since February. She is the founding lead of the BRAVE AI Validation Working Group, a cross-industry initiative with FDA participation building the first risk-based framework for validating AI in clinical trial operations.

Before founding the company she spent nine years in large pharma designing and scaling RBQM and forensic audit analytics from the ground up.

Her degrees are in mathematics from NYU Courant and statistics from Columbia.

If your RBQM program buries the three signals that matter under three hundred that don’t, come find her.