Posts by LMK Clinical Research Consulting
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…
Read MoreDefeating 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…
Read MoreYour 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…
Read MoreInformed 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?…
Read MoreWhen 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…
Read MoreWhen Medicines Go On Trial, LMK Makes Sure They Get It Right
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…
Read MoreInvestigative 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…
Read MoreWelcome to LMK Clinical Research
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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