Webinar

Smarter Audit Trail Review: Agentic AI Strategies for Modern Data Managers

Jun 11, 2025, Wednesday
11:00 AM EST

Join us for an insightful session—in collaboration with the Society for Clinical Data Management (SCDM). This session explores the evolving role of Audit Trail Review (ATR) in decentralized and hybrid clinical trial models, emphasizing its impact on data quality, regulatory compliance, and the day-to-day responsibilities of Data Managers. We’ll unpack how Data Managers can efficiently handle audit data from diverse systems with the help of Agentic-AI solutions and leverage ATR insights for proactive risk management.

Key Takeaways:

Understand the growing complexity of audit trails particularly in decentralized trials and why traditional discrepancy management alone may no longer be sufficient.

Go beyond checklist compliance by learning how Data Managers can use audit trail data throughout the trial to spot unusual patterns, monitor site behaviors, and support proactive risk management within RBQM.

Explore practical strategies and tools, including Agentic AI-enabled platforms, to streamline ATR processes and reduce manual burden during database lock and submission readiness.

Register now to discover how audit trail review is evolving—and how your team can stay ahead by embracing smarter, risk-focused data oversight practices.

Speakers

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Joanne Gonzalez

Vice President of Operations, LyfeSci Research & Innovation

As Vice President of Operations at LyfeSci Research & Innovation, Joanne brings over 18 years of leadership in clinical operations and data management, consistently advancing innovation and operational excellence across the healthcare sector. She is also the founder and principal consultant of ClinicalEdge Consulting, LLC, where she offers specialized advisory services to organizations seeking expert guidance in optimizing clinical operations and data strategies.

Indrani Kakade

Consultant, Clinical Trials; Data Management & Analytics

Indrani Kakade is a distinguished leader with over 29 years of experience in Global Pharma and Outsourcing Industry. She is an early adopter of Clinical Data Management Outsourcing to India with experience in Study set up, Data Management , Statistical programming, Drug Safety & Pharmacovigilance/Drug Safety Operations. She has held leadership roles at Pfizer Pharmaceuticals, Cognizant Technology Solutions, Sciformix Technologies, and Cliantha Research. She is known for her entrepreneurial skills in establishing and managing global operations and teams, having successfully led numerous large-scale projects and clinical study transitions across multiple geographies. Currently works as an independent consultant for pharma, CROs and technology companies in the area of data management and analytics leveraging automation, AI and ML concepts.