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LMK Blogs

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

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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A Series of Unfortunate Events… In the TMF

“No-one goes to work to do a bad job!” This quote, penned by legendary management thinker W. Edwards Deming, was introduced to us by a friend of LMK, process improvement and human factors guru, Keith Dorricott. In a recent LMK webinar, Keith discussed best practices for TMF metrics, and arrived at the conclusion that this

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Is Your TMF Ready For GDPR? Part Three: Know Your Responsibilities

Is your TMF ready for GDPR? This is the third and final post of a series examining how the new European Union General Data Protection Regulation could affect your trial master file. See part one and part two which examine the basic roles within GDPR and the foundational rights of data subjects. Serious Penalties and

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Bridging The ISF-TMF Divide: What Roles Should Sponsors & Investigators Play?

Regulation, more than just stipulating what must be done, must also define whose job it is to complete the task. The assignment of responsibility within the regulatory framework surrounding the clinical trial is essential to protecting the well-being of subjects and the validity of the trial’s data. Clear demarcation of the primary roles of sponsor

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Is Your TMF Ready For GDPR? Part Two: Know Your Rights

Is your TMF ready for GDPR? This post is the second article in a three-part series examining how the new European Union General Data Protection Regulation could affect your Trial Master File. In our last post on the European Union General Data Protection Regulation (GDPR) we examined the primary roles found within the regulatory framework

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Is Your TMF Ready For GDPR? Part One: Know Your Roles

This post is the first in a two-part series outlining how the new European Union General Data Protection regulation could impact your Trial Master File. Since 1995, EU Directive 95/46/EC has provided the foundation for “the protection of individuals with regard to the processing of personal data and on the free movement of such data”.

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The Silliest Thing We Can Imagine

Elon Musk decided to test his revolutionary Falcon Heavy rocket with the “silliest thing we can imagine”. Usually test payloads for new rockets are made of boring hunks of steel and concrete, but if Elon’s past actions are any indication –see his Boring Company branded flamethrower— normal just wouldn’t do. So Musk tweeted out this

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The Spirit of the Olympics in your TMF

The PyeongChang Olympics have begun with a flurry of inspiring headlines: Shaun White takes the gold medal and regains his crown’ Russian athletes allowed to compete despite doping controversy’ Unified Korean women’s hockey team takes the ice under united one flag’ These headlines give us hope that the Olympic Games reflects the best of humanity.

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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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