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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 … 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   Connie Orander, one of our TMF Consultants, embodies a great team member. Connie has been with LMK for slightly over a year. She is always willing to lend a hand to her coworkers. … 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 … Read more

Emails: To File or Not To File?

Emails.  It’s a love – hate relationship.  We loathe a full inbox when returning from vacation because those emails represent how far behind we are with our work.  Even during normal business hours, nonstop emails can draw our attention when we are trying to close out our workday.  It can be hard to turn off … Read more

Meet the LMK Team: Allison Grosik

At LMK, we acknowledge we could not be successful without our incredible team. This month we interviewed Allison Grosik, one of our dedicated TMF Support Analysts. Allison has been with the team for 6 months. Allison shares with us what she enjoys about her key role at LMK, her most memorable project, and her retirement … Read more

Meet the LMK Team: Marielle Hewitt

At LMK, we consider our dedicated team the key to our success. This month we interviewed Marielle Hewitt, one of our diligent TMF Support Analysts. Marielle has been with our organization for five months, and her contributions are crucial to our success. Learn about Marielle’s key role at LMK, her most memorable project, and the … Read more

Meet the LMK Team: Jason Badamo

“Great things in business are never done by one person; they’re done by a team of people” – Steve Jobs. This month we interviewed Jason Badamo, TMF Auditor, who has been a member of the team for one and a half years. Learn what Jason’s proudest moment at LMK is, his most memorable project, and … Read more

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