6th Trial Master File Summit – 6th Trial Master File Summit

A TMF 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 6th Trial Master File Summit, 40+ speakers will share best practices on how to:

  • Increase quality by implementing QC
  • Implement and utilize TMF metrics
  • Develop TMF milestones and SOPs to ensure timely document submission
  • Select when and where to use a CRO’s eTMF instead of an internal system
  • Establish an eTMF system to increase quality
  • Meet training and staffing needs for a TMF
  • Improve clinical operations in TMF management
  • Prepare for when regulatory authorities ask for eTMF access

The summit will also provide a comprehensive overview of necessary documents within the TMF and preparation strategies for inspections.

Top Five Reasons to Attend

  1. Learn from case studies and best practices for designing and implementing a TMF plan for global trials
  2. Ensure a compliant TMF that is inspection ready
  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

Who Should Attend

This conference is designed for representatives from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in the following areas:

  • TMF and eTMF Management
  • Clinical Document/Data Management
  • Clinical Trial Administration
  • Clinical Operations
  • Regulatory Affairs/Operations
  • Trial, Document and Record Management
  • Clinical Document Coordination
  • Clinical Development/Study Management
  • Quality Assurance/Control/Operations
  • Competency Development
  • Strategic Operations and Planning
  • Quality Management
  • Informatics
  • Clinical IT

This program will also be of interest to:

  • eTMF Service Providers
  • Data/Records Management Vendors
  • Clinical Research Organizations
  • Paper and Electronic Archiving Solution Providers