Webinar
Smarter Audit Trail Review: Agentic AI Strategies for Modern Data Managers
Learn how modern data managers can use audit trail insights and Agentic AI to improve data quality, regulatory compliance, and proactive risk management.
About this webinar
Presented in collaboration with the Society for Clinical Data Management (SCDM), this session explores the evolving role of Audit Trail Review in decentralized and hybrid clinical trial models.
Discover how audit trail review affects data quality, regulatory compliance, and the day-to-day responsibilities of Data Managers as clinical data increasingly flows through diverse systems.
Learn how Agentic AI solutions can help teams handle audit data more efficiently and turn audit trail insights into proactive, risk-focused oversight.
Key takeaways
- Understand the growing complexity of audit trails in decentralized trials and why traditional discrepancy management alone may no longer be sufficient.
- Go beyond checklist compliance by using audit trail data throughout the trial to identify unusual patterns, monitor site behaviors, and support proactive risk management within RBQM.
- Explore practical strategies and Agentic AI-enabled tools that streamline audit trail review and reduce manual effort during database lock and submission readiness.
Watch On-Demand
Get instant access to practical insights on using AI to strengthen clinical data oversight, manage risk, and accelerate decisions.
Speakers
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 the global pharmaceutical and outsourcing industry. She began her career in Clinical Data Management Outsourcing to India with experience in study setup, data management, statistical programming, drug safety, and pharmacovigilance operations. She has held leadership roles at Pfizer Pharmaceuticals, Cognizant Technology Solutions, Sciformix Technologies, and Cliantha Research. Known for her entrepreneurial skills in establishing and managing global operations and teams, she has led numerous large-scale projects and clinical study transitions across multiple geographies. She currently works as an independent consultant for pharma, CROs, and technology companies in data management and analytics, leveraging automation, AI, and ML concepts.
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