Embracing the Future: Leveraging Technology in TMF Management

Technology is rapidly transforming how Trial Master Files are managed. With advancements in artificial intelligence and cloud-based platforms, teams now have powerful tools to simplify workflows, reduce errors, and support audit readiness.

In this session, Katherine Cianciarelli and Jeanmarie Mathieu will explore how technology is enhancing TMF processes from every angle. They will walk through best practices for implementing AI tools that assist with quality control, adopting cloud solutions for better accessibility, and aligning digital workflows with regulatory requirements.

You will learn how to: 

• Use AI to automate repetitive tasks and flag document discrepancies 

• Improve cross-team collaboration through cloud-based TMF platforms 

• Ensure compliance with evolving standards like ICH E6 R3 and 21 CFR Part 11 

• Overcome adoption challenges and ensure a successful rollout of new tools

This session will provide a practical roadmap for clinical teams ready to evolve their TMF strategy. Whether you are starting your digital transformation or optimizing current systems, you will leave with ideas that can immediately strengthen TMF performance.