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A TMF™ system is more than a living archive of a clinical trial’s progress; it is a system required by regulatory authorities and is critical for clinical oversight. By developing, implementing and utilizing a sound TMF plan, you will be able to monitor a trial as it advances, ensure high-quality documents and prepare your organization for an inspection at any stage. Additionally, by creating a TMF process, the clinical trial’s sponsors, CRO, and site will be able to demonstrate their continued adherence to GCP during the trial.

At the 7th Trial Master File Summit, 40+ speakers will share best practices on a wide range of topics including:

  • Quality TMF process improvement
  • System migration and eTMF implementation
  • Determining and Managing Relevant communications in the TMF process
  • Completeness review by the study team and how to streamline this process
  • Maintaining a real-time TMF system and implementing processes to maintain a real-time eTMF system
  • Senior Management acceptance/funding/championing of eTMF implementation
  • Metrics with CRO and internal staff
  • How to construct a successful TMF team
  • Involving functions in TMF systems
  • Relevant correspondence, working with CRO partners, inspection readiness
  • Document management and processes
  • TMF QC or TMF process implementation
  • Inspection readiness, metrics, sponsor oversight responsibilities
  • Nothing specific at this time
  • CRO's and their SOP's and standards
  • Study Close-out/Transfer
  • How to set up a successful TMF staff. How to reduce the number of correspondence by downsizing the number of emails

Top Five Reasons to Attend

  1. Learn from case studies and best practices for designing and implementing a TMF plan for global trials and inspectional readiness
  2. Networking and learning with over 250 TMF colleagues
  3. Hear updates on the DIA reference model and MCC’s metrics working group
  4. Develop a TMF strategy to ensure proper TMF oversight
  5. Explore the latest trends, preparations and expectations for TMF inspections from the FDA, EMA, MHRA and PMDA

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