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FBW TMF Intro

Where Metrics, Oversight and Digital Innovation Converge

Gain insights into building a compliant, quality-driven TMF with risk-based oversight, automation, and AI to support global inspections and proactive decision-making. Discover how collaborative TMF systems are evolving to meet the demands of decentralized and digital trials.

Registration is FREE for Biotech, Pharma, Investors & Clinical Sites Professionals — but only for a limited time!

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Be part of the premier event shaping the future of biotech and pharma.

Qualifying professionals can attend Fierce Biotech Week for free—must work in biotech, pharma, investment, and clinical site roles. Apply now for a FREE VIP Pass.

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Be part of the TMF Community that is collectively identifying key solutions.

Best practices to drive inspection readiness
Best practices to drive inspection readiness
Gain insights on best practices for establishing and monitoring metrics to drive inspection readiness and inform proactive decision-making in clinical trials.
Building a TMF organization with a culture of quality
Building a TMF organization with a culture of quality
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.
Risk-based approaches to ensure vendor oversight and data governance
Risk-based approaches to ensure vendor oversight and data governance
Build a compliant monitoring framework using risk-based approaches and methods to ensure vendor oversight and data governance.
Improve the quality and consistency of TMF by leveraging AI
Improve the quality and consistency of TMF by leveraging AI
Explore the latest automation and process improvements utilizing AI and machine learning as new inspections methods, digital, and decentralized trials become more common .
Harnessing AI and technology to accelerate trials and expand patient reach
Harnessing AI and technology to accelerate trials and expand patient reach
Explore process innovations and technologies like AI and wearables that are reducing the trial cycle and connecting researchers to more patients

Key topics covered in the Trial Master File Sessions:

  Inspections and audits

  Operations and collaboration

  Governance and oversight

  AI Innovation, technology and automation

  TMF Strategy 

FBW TMF Topics