LMK Blog

The Zombie TMF

October 30, 2017

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

October 24, 2017

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

October 18, 2017

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

October 5, 2017

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.

October 5, 2017

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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When Medicines Go On Trial, LMK Makes Sure They Get It Right

August 24, 2017

SUPPLIER DIVERSITY – WBENC CERTIFIED Editorial Sponsored by Bristol-Myers Squibb By Arthur Schurr Bringing a medicine to market is not easy. It takes time. It takes money. It takes research. But it also takes something else that is surprisingly often overlooked—documentation. And that’s exactly why Sholeh Ehdaivand founded LMK Clinical Research Consulting (LMK). “I had been…

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

August 14, 2017

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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Welcome to LMK Clinical Research

August 3, 2017
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eTMF Placeholder: The Mirage of the TMF

June 6, 2017

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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