Posts by LMK Clinical Research Consulting
Facing TMF Bias: My Role is Not Entry Level PART TWO
Part Two: I tenaciously strive for TMF success. 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 left…
Read MoreFacing TMF Bias: My Role is Not Entry Level PART ONE
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. By the time they are proficient, they leave to embrace a new specialty. This need not be the reality. There is no revolving door where I…
Read MoreThe Importance of a Single Document
While working within a Trial Master File (TMF), it can often seem like there is no end to the number of documents needed for a clinical research study. There are multiple documents for different aspects of a study – from trial management to site management, safety, statistics, data management and everything in between. But one…
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…
Read MoreLMK Helps Medline, A Large Medical Distributor, Optimize Their Use Of Veeva
Situation: Medline, a large manufacturer and distributor of medical supplies, migrated from a paper TMF to an eTMF system, Veeva, in order to have better control and visibility of the condition of their TMF at all times. While the goal was clear, the combination of limited TMF resources to implement the system and the team’s…
Read MoreMeet the LMK Team: Connie Orander
“It is teamwork that remains the ultimate competitive advantage, both because it is so powerful and so rare.” – Patrick Lencioni, Co-Founder of the Table Top Group and Pioneer of the Organizational Health Movement Connie Orander, one of our TMF Consultants, embodies a great team member. Connie has been with LMK for slightly over a…
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