Smarter Audit Trail Review: Agentic AI Strategies for Modern Data Managers
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
Varsha Kishore
Product Management Leader, Maxis AI
Varsha Kishore Product Management Leader·Maxis AI Varsha Kishore is a strategic Product Management Leader at MaxisIT, where she spearheads the conceptualization and end-to-end delivery of flagship Agentic AI products. With over ten years of experience in clinical IT and Pharmaceutical industry, she has evolved from a high-impact Business Analyst into a visionary leader specializing in the integration of AI frameworks within GxP-compliant clinical trials. Varsha is recognized for orchestrating high-performing cross-functional teams to drive innovation and operational excellence.
Dr. Rachna Saralkar
Product Management Leader, Maxis AI
Dr. Rachna Saralkar is a double board-certified physician and Principal Investigator at Flourish Research, specializing in psychiatry, clinical informatics, and the application of AI in healthcare. She brings deep expertise at the intersection of clinical research, digital health, and emerging technologies, with a focus on advancing more efficient and patient-centered clinical development. Previously, she served as Medical Product Director at Deliberate AI, where she led the development of AI-enabled solutions for mental healthcare. She has also advised several early-stage health technology startups as a fractional Chief Medical Officer. Dr. Saralkar completed her psychiatry residency at Johns Hopkins University and holds a Master’s in Clinical Informatics Management from Stanford University School of Medicine.
