Avoiding the Naughty List: Inspection Readiness at the 8th TMF Summit

With lights in the trees, wreaths on the doors, and Mariah Carey’s ‘All I Want for Christmas’ playing on every other radio station, it must be that time of year again… time to prepare for the annual Trial Master File Summit in Orlando!


This year, LMK Clinical Research Consulting (LMK) is feeling extra festive, because at the upcoming TMF Summit in Orlando (January 22nd through the 24th), LMK will be bringing a sleigh full of experience with them to Orlando.


At the summit, LMK will be leading a session on the topic of TMF Inspection Readiness.


During the session LMK will be speaking about how to avoid the clinical research equivalent of the lump of coal: the negative inspection finding. In order to keep you and your TMF in Santa’s (and FDA’s) good graces, her session will focus specifically on how to account for the variability that impacts your TMF’s quality management system. We will cover a full spectrum of inspection readiness activities and will show you how to:


  • Evaluate quality control processes based on viability and efficacy
  • Compare roles and expectations of CROs of varying sizes
  • Deliberate the merits and drawbacks of training and support programs
  • Discuss key components and pitfalls of TMF Management
  • Identify and overcome barriers to CRO oversight and QC

Jackie Morrill is attending this year’s Summit as your best resource to learn all about LMK’s TMF services. Jackie, Director of Clinical Operations at LMK, is a Lean Six Sigma Green Belt certified clinical research professional with over a decade of experience in clinical trial coordination and process improvement within the healthcare, biotech, and pharmaceutical industries. Her experience includes oversight of eTMF implementation, development of robust metrics and training programs, enhancement and development of TMF processes, and extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections. She looks forward to learning more about your organization’s specific TMF goals and challenges.


So, as you drink your eggnog and relish this year’s Holiday Cheer, make plans to secure a better TMF New Year by attending the 8th annual TMF Summit in Orlando. Registration for the Summit is still open, and tickets make a great stocking stuffer for your clinical operations team.  The Holidays are the most wonderful time of the year because they renew our commitment to the values of peace, harmony, and unity. Come join LMK at the 8th TMF Summit in Orlando and preserve these Holiday values in your TMF all year long.