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LMK Blogs

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

Your Worry Free Migration to eTMF

In a recent blog post, Sholeh Ehdaivand, President and CEO of LMK Clinical Research Consulting, discussed the benefits of migrating from paper or hybrid TMF to eTMF. In her blog post, Sholeh wrote at length about the potential of a “shiny, new eTMF system”. Simply put, the transformative potential of the eTMF is astounding.  Beyond

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4 Reasons You’ll Be Happier When You Ban the Note to File

The New Year is a time to examine old routines and make new ones. Early in the year, we all can embrace a blank calendar and blank slate of ideas, goals, and resolutions. This year, at LMK, we’re challenging you to take up our resolution – to ban the Note to File (NTF). Yes, our

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How To: File a Certified Copy (and Leave Paper Behind)

About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise.   Celebrating

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How To: How to Use E-Signatures

About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise.   Celebrating

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Avoiding the Naughty List: Inspection Readiness at the 8th TMF Summit

With lights in the trees, wreaths on the doors, and Mariah Carey’s ‘All I Want for Christmas’ playing on every other radio station, it must be that time of year again… time to prepare for the annual Trial Master File Summit in Orlando!   This year, LMK Clinical Research Consulting (LMK) is feeling extra festive,

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LMK Remembers the 100th Anniversary of World War I

LMK Clinical Research Consulting recognizes our debt to all veterans, past and present. We acknowledge their sacrifice that ensures all Americans may share in our most important principles of freedom, justice, and liberty. These fundamental principles are the foundation of all worthwhile scientific and medical advancement. November 11th, 2018 marks the 100th year anniversary of

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How To: How to Decide When to Write a Note to File

About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise.   Celebrating

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How To: Make Sense of an Unfamiliar TMF

About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise.   Celebrating

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How To: Determine on What TMF Level a Document Should Be Filed

About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise.    Celebrating

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How To: Use the TMF Reference Model

About LMK’s How-To Series What makes someone an expert? Does it take a title, authority, or skill? At LMK we believe an expert, above all, is someone with the heart of a teacher—someone who doesn’t just possess advanced knowledge but is also willing to share that knowledge for the benefit of all.   LMK’s commitment

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Surviving Protocol Amendments: Preparation is Key

Of all the challenging aspects of managing a Trial Master File (TMF), grappling with a high number of protocol amendments nears the top of the list.  With every new amendment comes the need to produce, track, and file all the documents that have changed in tandem with the amendment. The number of documents that may

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Diagnosing Double Vision

One of the golden rules of Trial Master File (TMF) management is to avoid duplicate filing of documents.  We all know that the primary objectives of the TMF is to provide step-by-step documentation of the clinical trial and to protect the rights of patients.  It is also vitally important for the TMF to facilitate, and

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Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC

Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the Trial Master File (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not

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TOP 10 Things to do for DIA 2018 in Boston

Come meet LMK at booth 823 at DIA! We think it’s fitting that an event that will shape the future of the pharmaceutical industry is held in a city that is both entrenched in the history of our country and fully committed to the innovations of the future. Although LMK isn’t local to Boston, we

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Have More Than Faith: Have Conviction

A Message from Sholeh Ehdaivand President and CEO of LMK Clinical Research Consulting Sometimes when we are watching TV together, and an ad for a new drug comes on screen, my kids will ask, ‘Mom did you work on that?’ Sometimes I can say, yes I did! My first step as an entrepreneur was made

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Top 10 reasons to implement the TMF Reference Model

In anticipation of the release of version 3 of the TMF Reference Model and in honor of David Letterman’s last “Late Show” appearance, this post mimics his famous Top 10 list. Here are the Top 10 reasons to implement the TMF Reference Model. Enjoy! #10. You can finally answer the question “does this document belong

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Three Key Conclusions: New MHRA GCP Inspection Metrics

Great Britain’s MHRA (Medicines and Healthcare products Regulatory Agency) is known (and feared) for their high expectations regarding the TMF. MHRA expects your TMF to be “the story of how the trial was conducted and managed.” Their “inspectors want to reconstruct the trial conduct so that it can be evaluated for compliance …[and] review any

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