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eTMF Placeholders – 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 ALWAYS have to go back and try to piece together which documents should be present in the TMF!” I gushed to my colleagues how these PHs would magically make us more efficient and reduce our review times. After working further in the system, I realized... Read More

What the New England Patriots’ Super Bowl Win Can Teach Us About the TMF

On Sunday evening, millions tuned in to watch the team everyone loves to hate (the New England Patriots, of course) make their ninth Super Bowl appearance in a 1:1 match-up against the Atlanta Falcons. For the first three quarters, it seemed as if the Falcons had “risen” and were on their way to take home the coveted Vince Lombardi trophy. The game took a turn, and lo and behold, Tom Brady and his band of bandits shut down the Birds with an overtime win. At first glance you may be thinking, “What does the Super Bowl even have to do... Read More

To Migrate or Not to Migrate ? That is the Question

You have a shiny new eTMF technology with all of the bells and whistles that you and your team thought would only be possible in your dreams!  Finally, TMF documents can be loaded without a second thought to inspection readiness because this new system provides instant access on your computer screen to what is present or not.  It’s TMF utopia or so you thought. What are the benefits associated with eTMF implementation? It’s true. There are SO many benefits to implementing an eTMF system, such as: Improved inspection readiness Immediate access to TMF documents Remote oversight of the TMF Improved... Read More

Veeva 2016 Paperless TMF Survey

At the 2016 Drug Information Association (DIA) conference in Philadelphia a few weeks ago, Veeva released the third annual Veeva 2016 Paperless TMF Survey. The goal of this 13-question Survey (many of which included sub-questions with response matrices) was to further understand the impact of the electronic TMF (eTMF) adoption on clinical processes and the associated drivers, benefits, and expectations of such adoptions. The Survey findings represent the experiences and opinions of clinical professionals—217 TMF owners—across the globe. Business Drivers & Benefits of Adopting an Advanced eTMF Application According to the findings, several business drivers have motivated sponsors to implement... Read More

TMF Quality Control or TMF Inventory: What’s the Difference?

Over the years, I have participated in and managed a number of TMF Quality Control (QC) projects, and it has become one of my favorite activities. It’s one of the reasons I am facilitating the Metrics Champion Consortium (MCC) initiative on the TMF and leading the quality work stream for the TMF Reference Model. One thing I have seen over and over are TMF inventories camouflaging themselves as TMF QC outputs. So, what’s the difference? Are you performing a true TMF QC based on expectations? By definition, “quality control” is “a system for verifying and maintaining a desired level of... Read More

Five Reasons Why TMF Training is Important

Training is a vital component of workplace efficiency especially when it coms 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% over the previous year.  If you are lucky enough to oversee the TMF, you spend so much time bringing the right employees onboard, it only makes sense you would understand the importance of providing them with the proper training to ensure your TMF is always... Read More

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 the one that was just announced recently announced—Pfizer and Allergan.  Who knew these two large companies would combine to create one mammoth pharma powerhouse— “Pfallergan” (Thank you theguardian.com). Along with these M&As, come a lot of change: some obvious such as departmental reorganizations and others... Read More

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 CRAs and study coordinators sometimes think that they are a regulatory requirement.” Yes, we all know the golden rule of research: if it isn’t written down it didn’t happen. But, there is a limit to what warrants a NTF. If NTFs... Read More

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