LMK Blog

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

February 9, 2017

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…

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Leading Trial Master File Consulting and Services Provider Also Recognized as Industry Innovator

January 9, 2017

January 4, 2017 – Huntersville, NC – LMK Clinical Research Consulting, a leader in Trial Master File consulting and services has been named the winner of two Bronze Stevie® Awards: Maverick of the Year and Innovator of the Year in the 13th annual Stevie Awards for Women in Business. The Stevie Awards for Women in…

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TMF Trackers: Powering Your TMF for Inspection Readiness

October 11, 2016

Vol. 10, No. 10, October 2016, Journal of Clinical Research Best Practices – A Trial Master File (TMF) consists of the “Essential Documents…that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the…

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To Migrate or Not to Migrate? That is the Question

September 22, 2016

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…

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Veeva 2016 Paperless TMF Survey

August 29, 2016

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…

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Company Spotlight: LMK Clinical Research Consulting

August 16, 2016

August 11th, 2016 – IvyExec, Executive Insights – The process of conducting a clinical trial can be long and grueling. Throughout the research journey, it is essential that the trial sponsor rigorously maintains documents and content to ensure the quality and precision of the data gathered. Furthermore, regulators can require access to these documents and content…

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LMK’s TMF University Adds Three Experienced Clinical Research Instructors to its Faculty

June 14, 2016

14 June 2016, Huntersville, NC — LMK Clinical Research Consulting, LLC (LMK), a functional service provider of Trial Master File (TMF) consulting and services, announces the addition of three experienced professionals as instructors for its highly rated service offering, TMF University. “We believe the TMF is one of the most important deliverables of any clinical…

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

May 20, 2016

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…

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LMK Clinical Research Announces Creation of TMF University

February 29, 2016

23 February, 2016, Huntersville, North Carolina LMK Clinical Research Consulting, LLC (LMK), a functional service provider of Trial Master File (TMF) consulting and services, today announced the creation of TMF University. With the implementation of electronic TMF (eTMF) technology, TMF filing guidance, and most importantly greater scrutiny by the regulatory agencies on the TMF, the need for qualified and well-trained…

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