Blog Posts

2019 TMF RM Survey Results Summary

May 12, 2020

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…

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Meet the LMK Team: Sheila Garland

May 5, 2020

“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.…

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Emails: To File or Not To File?

May 1, 2020

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…

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Meet the LMK Team: Allison Grosik

April 28, 2020

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 six months. Allison shares with us what she enjoys about her key role at LMK, her most memorable project, and her retirement…

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Meet the LMK Team: Marielle Hewitt

March 23, 2020

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…

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Meet the LMK Team: Jason Badamo

March 3, 2020

“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…

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Meet the LMK Team: Jackie Morrill

February 20, 2020

At LMK, we believe that our dedicated team is the key to our success. This month we interviewed Jackie Morrill, our Executive Director of Clinical Operations, who has been with the team for 4 years. Jackie tells us what she enjoys about her key role at LMK, her most memorable project, and what her go-to…

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Know Your Regs: A TMF Regulatory Overview

January 28, 2020

Part 3: 21 CFR Part 11 As part of a recent webinar series, LMK Clinical Research Consulting was lucky to host Marie-Christine Poisson-Carvajal, Head of TMF & Registry Operations at Pfizer, to discuss the main regulations that predicate the Trial Master File. During the webinar, Marie-Christine outlined the four most common relevant regulatory authorities and…

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3 Ways Your eTMF Can Be the Champion of Your Clinical Trial

January 17, 2020

Visit LMK at the 9th Annual TMF Summit Now that the holiday season is over, the TMF experts at LMK are refreshed, reenergized, and ready to help you tackle your most pressing TMF challenges in 2020. As part of our mission to ensure TMF success for all, we’ll be attending the 9th annual Trial Master…

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