Facing 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 More
The 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 More
Where 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 More
LMK 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 More
How 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 More
GCP 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 More
Meet 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…
Read More
2019 TMF RM Survey Results Summary
The Trial Master File Reference Model (TMF RM) group has announced the results of their 2019 TMF survey, which was launched in November 2019. The purpose of the TMF Survey is to gather industry-wide insights of TMF/eTMF management and knowledge of the reference model. The data collected is used to identify new TMF trends, measure…
Read More
Meet the LMK Team: Sheila Garland
“TEAM. Together. Everyone. Achieves. More.” To keep our “Meet the Team” blog series going, we interviewed Sheila Garland, who has worked at LMK for a little over a year. Sheila tells us what she enjoys about her key role at LMK, what skills she attributes to her success, and what she would like to have an unlimited supply of.…
Read More