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LMK Blogs

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

Romance in the TMF

I bet you are familiar with those cliché candy hearts, but did know those little hearts share some history with the pharmaceutical industry? Conversation hearts were first invented in 1847, when Boston pharmacist Oliver Chase decided he wanted to make his fortune in the apothecary lozenge fad of the mid-1800s.  While Chase was working as

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TMF Summit 2018 – Top Three Trends

It was a pleasure attending this year’s TMF Summit for many reasons. Here are the top three trends in TMF that I noticed throughout the presentations: Focus on the TMF (Trial Master File) varies greatly by company. I was surprised to see that even some of the bigger companies in attendance have only made the

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TMF Game-Plan: Penalty Avoidance

No matter who you wanted to win the Super Bowl, we can all agree that the officiating of the game played an unusually large role in the outcome of this season. A series of key calls seemed to tilt the odds in favor of the Patriots—much to the frustration of everyone but Pats fans. The

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Staying out of the Ozarks: Financial Disclosure and the TMF

Up until the day everything changed, Marty thought he lived the perfect life. Marty had the wife, the colonial framed by a white picket fence, and two picture-perfect children. Marty was reserved, logical, and in control. Marty was a top earning financial advisor. Marty was awash in money. Unfortunately, Marty also washed money… for a

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What are your TMF Resolutions?

Why do we make resolutions? The idea of starting over with the New Year is an attractive one. After a long year, it’s human nature to detour into bad habits or lose sight of the incremental steps necessary to reach an important goal. But what are the resolutions we all have in common? Since we

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The Twelve Days of Quality Control (QC)

We know the Holidays can be a stressful time of the year. You and your team are doing their best to meet yearend goals while hanging up the lights and fighting mall traffic. We are happy to tell you that you’ve almost reached the finish line – happily, there are fewer than twelve days until

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Single Source of Truth: the Future of TMF Automation

Webinar Recap Sholeh Ehdaivand, CEO of LMK Consulting and Frederico Braga, principal of platform strategy and adoption at Medidata, recently spoke on a webinar how using technology such as Medidata Clinical Cloud can automate the management and creation of trial master files – accelerating processes such as study start-up for clinical ops and clinical IT.

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What We’re Thankful For This Year

For those of us in the North Carolina office, the frosty mornings of fall are finally upon us. We all know that at this time of year, if you blink, New Year’s Eve has already come and gone.  It’s the speedy arrival of the Holidays that causes us to reflect on how quickly things can

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The Zombie TMF

Happy Halloween from the team at LMK! We’ve been carving pumpkins, hoarding candy (some of which may survive for the trick-or-treaters), and shuffling along like zombies to Michael Jackson’s Thriller every time it pops up in our Halloween playlist. We know Halloween is scary for a lot of reasons, but realizing that the album Thriller

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Defeating your Demogorgon: TMF Inspection Readiness

This blog post is the continuation of our two-part Stranger Things series. Check out the first post, Your Way Out of the Upside Down: TMF QC. If you happen to be a big fan of Netflix’s hit show Stranger Things, you’ve definitely noticed the countdown to the season two premier ticking away on Netflix’s home

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Your Way Out of the Upside Down: TMF QC

The season two premier of Netflix’s hit show, Stranger Things, is less than two weeks away. Since we’re big fans here at LMK, we’ve been preparing a lot like you have: by re-watching episodes, obsessing over the new trailer, and daydreaming about what season two will hold. But at LMK, we aren’t just your normal

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Informed Consent: The Story Your TMF Needs to Tell

Of all the documents making their way into your TMF, the informed consent form is the most important. Although you probably already knew this fact, do you know how it came to be this way? Why do auditors and inspectors review 100% of the informed consent documents, and typically do so before reviewing anything else?

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When it comes to Inspection Readiness – Knowledge WINS.

Per GCP Directive 2005/38/EC: Chapter 4 Article 16, the Trial Master File (TMF) is THE basis for an inspection by the Regulatory Authority. The definition of TMF Inspection Readiness therefore includes being prepared for a regulatory inspector to reconstruct the clinical trial conduct, using all pertinent data and metadata in the TMF. Essentially, this means

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Investigative Site Files and Trial Master Files Should Talk to Each Other

The major deliverable of a clinical study is an organized collection of documents called a Trial Master File (TMF). The FDA (or any regulatory authority) may review the TMF to determine whether the drug, device or diagnostic product is suitable for marketing. The ICH Guideline for Good Clinical Practices (E6 (R2)) Section 8 specifies the

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eTMF Placeholder: The Mirage of the TMF

When I was first introduced to the concept of Placeholders (PHs) for eTMF over four years ago, I was SO excited! We were in the process of performing TMF reviews for hundreds (yes, hundreds) of studies. I thought, “YES, FINALLY, some intelligent engineer has figured out a way to determine TMF completeness automatically! We don’t

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To Migrate or Not to Migrate? That is the Question

You have a shiny new eTMF technology with all of the bells and whistles that you and your team thought would only be possible in your dreams!  Finally, TMF documents can be loaded without a second thought to inspection readiness because this new system provides instant access on your computer screen to what is present

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Veeva 2016 Paperless TMF Survey

At the 2016 Drug Information Association (DIA) conference in Philadelphia a few weeks ago, Veeva released the third annual Veeva 2016 Paperless TMF Survey. The goal of this 13-question Survey (many of which included sub-questions with response matrices) was to further understand the impact of the electronic TMF (eTMF) adoption on clinical processes and the

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TMF Quality Control or TMF Inventory: What’s the Difference?

Over the years, I have participated in and managed a number of TMF Quality Control (QC) projects, and it has become one of my favorite activities. It’s one of the reasons I am facilitating the Metrics Champion Consortium (MCC) initiative on the TMF and leading the quality work stream for the TMF Reference Model. One

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