Blog Posts
TMF Trackers: Powering Your TMF for Inspection Readiness
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…
Read MoreTo 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…
Read MoreVeeva 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…
Read MoreCompany Spotlight: LMK Clinical Research Consulting
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…
Read MoreLMK’s TMF University Adds Three Experienced Clinical Research Instructors to its Faculty
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…
Read MoreTMF 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…
Read MoreLMK Clinical Research Announces Creation of TMF University
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…
Read MoreFive 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%…
Read MoreHalloran Consulting Group Partners with LMK Clinical Research Consulting to Enhance Clinical Trial Master File Management and Process Planning
Boston, MA (PRWeb) January, 20 2016 Halloran Consulting Group, Inc. (Halloran), a national consultancy that works with global life science companies to optimize development and performance, today announced a collaboration with LMK Clinical Research Consulting (LMK), an industry document management services provider, to enhance and streamline Trial Master File (TMF) management and processes for pharmaceutical,…
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