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LMK Blogs

Get the latest updates from the LMK Clinical Research Team! New blogs are released periodically throughout the year.

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

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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

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Meet the LMK Team: Jackie Morrill

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

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

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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A Bright Idea Will Bring Us Together: Happy Holidays from LMK

Like so many tangled strands of holiday lights, making sense of an unhealthy TMF can bring out the opposite of holiday spirit. Still, LMK’s TMF experts have been working all year on the most challenging TMF problems. They have found obstacles that may at first seem impassable can be overcome when the right technology and

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Know Your Regs: A TMF Regulatory Overview

Part 2: MHRA Gray Guide As part of a recent webinar series, LMK Clinical Research Consulting was lucky enough 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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The Powerful Benefits of TMF Gratitude

At home with our family and friends and surrounded by delicious food and drink it is easy to count one’s blessings. The benefits of gratitude, however, are available all year long and extend far beyond the border of the Thanksgiving table. LMK’s TMF experts have even found that gratitude, a quality of open appreciation for

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Know Your Regs: A TMF Regulatory Overview

Part 1: ICH GCP As part of a recent webinar series, LMK Clinical Research Consulting was lucky enough 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 their

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TMF Horror Cliches

The Top 4 Horror Clichés Lurking in Your TMF With Halloween finally here, many of us are curling up on the couch with a bucket of candy and binge-watching horror movies. There are an abundance of these films to stream: cult classics, who-done-its, edge-of-your seat thrillers, gory slasher films, and the ever-popular zombie uprising. Some

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5 Narrative Elements That Will Reveal The Masterpiece In Your TMF

In response to the increasing opacity of the trial master file (TMF), clinical trial decision makers have embraced quantitative metrics as a way of characterizing and understanding the health of a TMF. Quantitative metrics are easily generated through the reporting functionality of a modern electronic TMF (eTMF) and appear to add value by leveraging the

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Constant Renewal: The Perennial TMF and GDP

“Life starts all over again when it gets crisp in the fall.” This famous passage from Fitzgerald’s novel, The Great Gatsby, suggests that the fall season is a time of renewal rather than the last hurrah before the dead of winter. As we celebrate fall and contemplate winter, we should also consider the changing seasons

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Best Practices: Smart Study Start-Up Leads to TMF Success

In a recent Veeva survey, 81% of respondents reported the ongoing use of manual processes (like spreadsheets and emails) to manage study start-up.[1] More worryingly, despite the recognized need for increased clinical operations transparency and efficiency, the same survey report cites that study start-up is no faster than it was a decade ago, even considering

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Best Practices: Contacting Trial Sites for Missing TMF Documents

Completeness is an essential component of TMF health. A TMF’s purpose is to tell the story of a clinical trial. An incomplete TMF is like a book with missing pages—even if the story is well written, it is inaccessible to any reader. In a few previous blog posts we’ve discussed how an incompleteness crisis can

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Recovery: The TMF Completeness Crisis

In our last post, we discussed the growing TMF completeness crisis. More often than ever, sponsors are discovering that upon closeout the TMF is woefully incomplete. Delays in TMF closure, as discussed in the last post, increase regulatory risk, derail regulatory submissions, and can endanger an entire project. Although a few key incompleteness mitigation strategies

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Prevention and Remediation: The Completeness Crisis

With increasing frequency, TMF stakeholders face a completeness crisis at TMF close-out.  Delays in TMF closure increase regulatory risk, derail regulatory submissions, and can endanger an entire project. Sponsors, when asked about the growing trend of TMF incompleteness, are likely to cite a challenging relationship with a CRO. Regulators, however, have little sympathy for this

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Transform Your TMF Team: The Rewards of TMF Training

Your choice of eTMF system, performance metrics, quality system, and any other TMF initiative are critical, but ultimately the success of your TMF is secured through the engagement and competency of your TMF team. At LMK, we believe the most important features of your TMF are people and that innovative TMF training is as important

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The Four P’s of Migration

Change isn’t easy. Although your current TMF system may no longer align with your team’s goals, the prospect of migrating to a new eTMF system can be intimidating. Selecting the correct eTMF system for your team’s needs is only an initial step. Deployment of a new eTMF system requires training, updated processes and SOPs, complete

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The Mindful TMF: Acceptance and Letting Go

About LMK’s Mindful TMF Series Your palms are sweaty. Your pulse races when you hear the news. You’d do anything for a few more hours to prepare and you might work all night. It’s TMF inspection day and now it’s too late to make a meaningful change. At LMK Clinical Research Consulting, we know the

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