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FBW TMF Intro

Gain insights on establishing and monitoring key metrics to drive inspection readiness and support proactive decision-making in clinical trials. 

Explore how to foster a culture of quality and strategic advancement as the TMF evolves into a collaborative management system. Learn how to build a compliant monitoring framework using risk-based approaches to ensure vendor oversight and data governance. Discover the latest advancements in automation, AI, and machine learning as digital and decentralized trials become more common and understand strategies for maintaining a compliant TMF amid evolving inspection trends and global regulations. 

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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