AI Governance in Clinical Trial Biometrics:
A Practical Framework for Small-Mid Size Organizations

Tai Xie obtained his PhD in Statistics from the University of Arizona. He is the Founder and CEO of CIMS Global and previously founded Brightech, which was acquired in 2022. Prior to that, he spent 10 years at pharmaceutical companies, including Pfizer, Johnson & Johnson and Eli Lilly, where he gained expertise in clinical trials, statistical analysis, reporting and regulatory submissions.

Tai advocates using open-source tools (R and Python) and AI in clinical trials. He leads a team of over 40 developers to build innovative platforms, such as Compliant R Environment (CRE), DMC-HUB and AI governance solutions.

Tai is a thought leader who shares insights on clinical data analytics and AI adoption on LinkedIn and other professional platforms. He specializes in adaptive trial design and co-invented Dynamic Data Monitoring (DDM), which has been used successfully in multiple clinical trials.

Peng Zhang is the Associate Director of Innovative Data Sciences Department at CIMS Global. He graduated from Rutgers School of Public Health with a PhD in Biostatistics and research interests in adaptive design and statistical monitoring of clinical trials.

Peng leads the internal development of R packages, R Shiny apps, agentic workflow and supports software development with open-source solutions. Peng has also served as an independent Statistician for 30+ DSMB meetings and 10+ ongoing clinical trials from Phase II-III for different therapeutical areas.

Christine is a Senior Director of Product Management with more than 20 years of experience in the clinical and life sciences industry and approximately 15 years in product management. Her work focuses on building and governing technology used in regulated environments, with particular emphasis on validated systems, data integrity, compliance and responsible AI adoption.

She has played a central role in defining governance approaches for the use of AI in clinical and biometrics workflows, including the development of frameworks for AI risk classification, human oversight, validation, auditability, data protection and controlled use of large language models. Her work addresses the distinction between enterprise access to AI and truly governed use, particularly when AI is applied to confidential, regulated or GxP-related information.

Christine has contributed to the design of AI governance models that incorporate human-in-the-loop review, traceable approvals, prompt and response audit trails, sensitive data controls, de-identification and re-identification safeguards and lifecycle management for AI-enabled assets. She is also involved in the development of ProvAI, a governed AI platform designed to support the creation, validation, approval and controlled execution of AI assets and workflows.

Her broader experience includes product strategy, validation documentation, regulatory compliance, statistical computing environments and cross-functional leadership across product, development, quality and customer-facing teams. She is particularly interested in practical approaches that allow organizations to adopt AI while maintaining appropriate governance, accountability and regulatory readiness.

Benjamin C. Eloff, PhD, is Vice President at Healthcare Innovation Catalysts and a Senior Scientific Advisor with more than 20 years of leadership in biomedical research, regulatory science and health innovation policy and nearly 20 of them in federal service at the FDA and the Department of Health and Human Services. He has held senior roles in medical device safety, evidence generation and innovation management and his expertise span real-world evidence, epidemiology and regulatory program design. He played a central role in establishing the National Evaluation System for Health Technology and he led the development of the FDA’s first guidance on the use of real-world evidence. He is a member of the DIA artificial intelligence (AI) consortium, where he co-chairs a workstream this year focused on the practical work of validating and implementing AI tools in regulated environments. He holds a PhD in Biomedical Engineering from Case Western Reserve University, and he is an Eagle Scout and a Grammy-winning musician.

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

She is the founding lead of the BRAVE AI Validation Working Group, a cross-industry initiative with sponsors, vendors and the FDA taking part, building a risk-based framework for validating AI in clinical trial operations. She also co-led the eClinical Forum working group that produced the Audit Trail Review Analytics industry position paper that was downloaded over 2,100 times since February.

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.

Jimeng Sun is a Professor of Computer Science at the University of Illinois Urbana-Champaign and Co-Founder & CEO of Keiji AI. His research focuses on AI and machine learning for clinical research and drug development, with publications in Nature Communications, npj Digital Medicine, NeurIPS and other leading venues. He works closely with biopharma and healthcare organizations to translate AI research into real-world clinical trial systems.