Webinar

Responsible AI in Clinical Trials: Building Trust through Human Oversight

Dec 16, 2025, Tuesday
11:00 AM EST

AI is transforming clinical trials, but with increased automation comes heightened concerns about trust, transparency, and human accountability. Missteps in AI-driven processes can risk data integrity, regulatory compliance, and stakeholder confidence. Ensuring human oversight is embedded in every step is critical.

This session introduces a risk-based oversight framework that keeps human intelligence central to AI workflows, including data validation, predictive modeling, and risk detection. Participants will see how to integrate human judgment alongside automation to strengthen decision-making.

Attendees will learn to implement Human-in-the-Loop, Human-on-the-Loop, and Human-in-Command models, designing Responsible AI systems that meet global regulatory expectations. Practical strategies for enhancing transparency, accountability, and accuracy in clinical AI workflows will be shared.

Key Takeaways:

Understand how to implement risk-based oversight frameworks in AI-enabled clinical environments
Learn to design and validate Responsible AI systems that comply with global regulatory expectations
Discover how human oversight enhances trust and decision accuracy in AI-driven workflows
Explore practical steps for aligning AI initiatives with quality, compliance, and patient safety goals.

Responsible AI is key to building confidence in clinical trials. Join this webinar to gain actionable approaches for balancing innovation with human oversight. Register now to learn how to integrate human oversight into your AI initiatives.

Speakers

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Laxmiraju Kandikatla, MPharm, CQA

CSV Lead, Maxis AI

Laxmiraju Kandikatla brings over 13 years of experience in life sciences, pharmaceutical, and clinical research sectors to his role as CSV Lead at Maxis AI. He holds a master’s degree in Pharmaceutical Sciences (M. Phar, NIPER) and is an ASQ-Certified Quality Auditor (CQA). In his role at Maxis AI, Laxmiraju leads the design and implementation of validation and compliance frameworks for systems used in clinical research and has hands-on experience in validating systems across GAMP 5 Categories (3, 4, and 5). He works directly with customers during implementation, aligning validation and compliance activities to ensure smooth delivery. He has extensive knowledge of GxP regulations, including 21 CFR Part 11, EU Annex 11, and FDA guidance. He is the author of “A Risk-Based Framework for Human Oversight in AI “, through which he advances ethical assurance frameworks centered on fairness, accountability, and transparency in AI Systems.

Rajesh Hagalwadi

Director, Clinical Solutions

Rajesh is a PMP- and CSM-certified professional who brings over 15 years of experience implementing eClinical systems within the life sciences industry. His expertise includes pre-sales engineering, product advocacy, solution implementation, computer system validation (CSV), and end-user training. He frequently collaborates with account executives to develop strategic account plans, conduct client discovery, and deliver impactful presentations that showcase the technological and business value of Maxis AI.