TMF Summit

Discover the Latest Inspection Trends, Regulatory Developments & Emerging Technologies for the TMF Community  

The role of clinical document management continues to rapidly evolve to meet the needs of complex clinical trials across multinational sites. TMF professionals, as experts in the subject, need to stay updated on system migration, efficiency improvements, budget constraints, partnerships, new technologies like AI/ML, and evolving regulations to maintain a high-quality and inspection-ready TMF.

For over a decade, the Fierce TMF Summit has been the cornerstone event for clinical operations, document management, technology, and compliance leaders, TMF administrators, and partners in the global trial master file community. Join your clinical document peers in collaborative discussions about regulatory changes, automation, interoperability, and enhancing stakeholder relationships to improve TMF quality, timeliness, and completeness.


Stay informed about cutting-edge strategies and emerging technologies that can make a significant difference in your TMF by keeping abreast of the most recent trends and innovations.


Join forces with your TMF colleagues and create valuable resources to lead your organization's TMF to its maximum potential through interactive workshops, presentations, case studies, and more.


Unearth the newest technologies to incorporate, enhancing an organization's quality, monitoring, and metrics to guarantee comprehensive TMF management.

Catering to the needs of every TMF professional with the following key focus areas:

Inspections & Audits

Gain insights on best practices for establishing and monitoring metrics to drive inspection readiness and inform proactive decision-making in clinical trials. 

Operations & Collaboration

Drive strategic advancement and build a culture of quality with the trial study organization from the start as the TMF evolves into a collaborative management system. 

Governance & Oversight

Build a compliant monitoring framework using risk-based approaches and methods to ensure vendor oversight and data governance. 

AI & Automation

Explore the latest automation and process improvements utilizing AI and machine learning as new inspections methods, digital, and decentralized trials become more common. 

TMF Strategy

Learn insights and strategies for implementing and maintaining a compliant TMF according to inspection trends and changing global regulations. 

Schedule at a Glance



Registration & Networking Breakfast


General Sessions

8:30am –12:45pm

Networking Lunch

12:45pm – 1:45pm

Tracked Sessions

1:45pm – 5:54pm

Networking Reception




Registration & Networking Breakfast


General Sessions

8:45am –12:00pm

Networking Lunch

12:00pm – 1:00pm

Tracked Sessions

1:00pm – 5:30pm



Registration & Networking Breakfast


Workshop A & B

8:45am – 10:15am

Workshop C & D

10:45pm – 12:15pm

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Become a Partner

Solidify existing relationships with clients and build strong connections with new decision-makers.