Key Updates for 2025

Fierce Trial Master File Summit will evolve into a new event called Fierce Biotech Week in October 2025.  Join us as we bring together Life Sciences communities to help biotech and pharma companies discover the latest scientific breakthroughs and optimize R&D and clinical operations. 

TMF Summit

The Premier Event 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.

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. 

Reasons to Attend the Fierce TMF Summit

Learn.

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.

Collaborate.

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.

Explore.

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

Savannah Guru Tips

Savannah's "Too Much Fun" Guide

Unlock the Charm of "The Hostess City of the South" with Elyse Nixon-Taft and Carrie Kittrell

Discover the enchanting allure of Savannah during the Fierce TMF Summit with Elyse Nixon-Taft and Carrie Kittrell, your ultimate guides to the oldest city in Georgia. Known as "The Hostess City of the South," Savannah boasts a rich history that beckons millions of visitors annually. Elyse, a former resident, and Carrie, a frequent visitor, share their insider tips on the best southern cuisine, craft cocktails, and must-try activities.

Download our guidebook to embark on a journey filled with expert recommendations, ensuring a truly unforgettable experience in Savannah!

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Learn more about the Quest Zero initiative and specific actions already being taken to reduce emissions at events like this one.

Quest Zero Initiative

Let’s reach net zero together!

Download tips so you can have a more sustainable event experience.

Partnerships

Become a Partner

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