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LMK Blogs

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

Five Reasons Why TMF Training is Important

Training is a vital component of workplace efficiency especially when it comes to one of the most important deliverables of a clinical trial – the Trial Master File (TMF). Perhaps that’s why, according to a recent article in Forbes magazine, US companies spent over $70 billion on corporate training in 2014, an increase of 15%

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Mergers, Acquisitions (M&A) and the TMF?…Oh My!

It seems that every time I open my MSNBC app, I read about yet another pharma/biotech merger and acquisition (M&A).  What exactly is an M&A anyway?  Investopedia defines a merger as “a combination of two companies to form a new company, and an acquisition as the purchase of one company by another.” My favorite is

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5 Pillars of the Trial Master File (TMF)

To build a strong TMF that is not only inspection ready at all times, but also reliable and credible is essential for the reconstruction of the conduct of any clinical trial during an audit or inspection process. The following 5 pillars of TMF success facilitate efficient trial management: 1. Standardized processes: There’s more than one

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Before you write that Note to File (NTF), read this!

This post is unconventional and perhaps a little unpopular, but it has to be said: more than likely, you are writing and filing TOO many NTFs for missing documents, signatures, and data. Enough is enough!   Carl Anderson said it best in his article from March 1, 2008 in Applied Clinical Trials, “The practice has become so ubiquitous that new

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2015 TMF Survey Yields Interesting Results

The Trial Master File Reference Model (TMF RM) team conducted the fifth annual TMF RM Survey from May to July 2015. The survey results were published last week and I would like to share with you some very interesting data about current TMF practices. SURVEY BACKGROUND As a sub-committee member of the TMF RM initiative,

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Is Your TMF “Fit”?

Effectively Operationalizing your Trial Master File Requires the human element. Like so many of you, I really love my Fit Bit. Nothing gives me more satisfaction then to see the counter turn to 10,000 each and every day. Unfortunately, the counter does not turn by itself. In order to reach my 10,000 step-a-day goal, I

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