Blog Posts
A TMF That Works With You: Achieving TMF Process Sustainability
Sustainable TMF processes are stable, repeatable, and scalable. Unsustainable TMF processes are poorly defined, constantly changing, time consuming, and introduce compliance risk. They make the workday a challenge and are a constant obstacle to our TMF goals. Nobody actively seeks to make a process unsustainable, of course, but achieving TMF process sustainability isn’t easy. Without…
Read MoreFacing TMF Bias: My Role is Not Entry Level PART THREE
Part Three: We begin with the end in mind. I’ve heard your TMF department has a revolving door. Contractors and young, fresh faces constantly churn through their first day on the job and last day in the office. This need not be the reality. There is no revolving door where I work. My team has…
Read MoreWhere Should I Begin?
Experience in various roles within clinical research greatly helps with having an understanding of the Trial Master File (TMF) but it’s not always necessary to have decades of experience in clinical research to be an effective TMF Analyst or Auditor. The most important thing to keep in mind when performing a TMF Quality Control (QC)…
Read MoreLMK Named an INC 5000 Fastest Growing Company For The Second Year In A Row
HUNTERSVILLE, August 12, 2020 – Inc. magazine today revealed that LMK Clinical Research Consulting, LLC is No. 2872 on its annual Inc. 5000 list, the most prestigious ranking of the nation’s fastest-growing private companies, with a three-year growth rate of over 138%. The list represents a unique look at the most successful companies within the…
Read MoreHow to Build a Strong TMF
Building a strong TMF that is reliable, credible, and inspection ready at all times is crucial for the reconstruction of any clinical trial. Successful TMF trial management can be facilitated by: Standardizing Processes: Implementing SOP’s for filing or QCing a TMF document ensures your team is consistently delivering the same quality of work. An SOP…
Read MoreGCP Inspections Metrics Report: Key Conclusions
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) is renowned and feared for its high expectations regarding the Trial Master File (TMF). MHRA expects your TMF to be “the story of how the trial was conducted and managed.” Given the MHRA’s expectations, it is no surprise that the TMF is well represented among…
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