Blog Posts

eTMF Placeholder: The Mirage of the TMF

June 6, 2017

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…

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LMK’s eTMF-Agnostic TMF Completion Process Revolutionizes Approach to Inspection Readiness

May 31, 2017

May 31, 2017 HUNTERSVILLE, N.C.–(BUSINESS WIRE)–LMK Clinical Research Consulting, LLC (LMK), a functional service provider of Trial Master File (TMF) consulting and services, is pleased to announce “LMK Complete,” an eTMF agnostic process to determine TMF completeness to support regulatory inspection readiness. [gdlr_quote align=”left” ]LMK Complete solidifies the most important aspect of any clinical trial,…

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LMK’s TMF University to Partner with UNC Wilmington to Prepare Students for a Future in Clinical Research

April 4, 2017

04 April 2017, Huntersville, NC  — LMK Clinical Research Consulting, LLC (LMK), a functional service provider of Trial Master File (TMF) consulting and services, is pleased to announce a partnership between the University of North Carolina Wilmington (UNCW) and our highly rated training program, TMF University.  LMK is the first and only TMF services company…

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LMK Clinical Research Consulting: Sustainable Processes for Clinical Trial Quality

March 11, 2017

March 2017, Pharma Tech Outlook Magazine – From being stored in cardboard boxes, to sophisticated online databases, the Trial Master File (TMF) has always been an essential component in every clinical trial, despite the evolution. Based on the singular belief that the TMF is the foundation of every clinical trial, Sholeh Ehdaivand has dedicated 15 years…

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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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