Posts by LMK Clinical Research Consulting
LMK’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,…
Read MoreMergers, 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…
Read More5 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…
Read MoreBefore 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…
Read More2015 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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