Blog Posts
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…
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,…
Read MoreLMK Announces Key Appointment To Its Executive Team, Further Demonstrating Its Commitment to TMF Quality Solutions & Services
8 June, 2015, Huntersville, NC –LMK Clinical Research Consulting, LLC (LMK), a functional service provider specializing in Trial Master File (TMF) management to the life sciences industry today announced the appointment of Shahrzad Slater, MD, MPH as Senior Vice President of Clinical Operations and a member of its Board of Directors. Based in LMK’s Boston…
Read MoreLMK Clinical Research Consulting, LLC Gains Women’s Business Enterprise Certification
25 March, 2015, Huntersville, North Carolina —LMK Clinical Research Consulting (LMK), a functional service provider specializing in Trial Master File (TMF) management, announces it received certification as a Women’s Business Enterprise (WBE) from the Women’s Business Enterprise National Council (WBENC). Founded in 1997, the WBENC is the largest, third-party certifier of women owned businesses in…
Read MoreLMK Clinical Research Consulting, LLC To Offer Expert Instruction On Trial Master File (TMF) Training In Online xTalks Course
06 October 2015, Huntersville, North Carolina -LMK Clinical Research Consulting, LLC (LMK) announces a collaboration with Xtalks eCademy to launch a new best-in-class virtual training course this October for life science professionals who are eager to learn best practices and trusted strategies for achieving excellence in their Trial Master File (TMF). Sholeh Ehdaivand, an industry…
Read MoreIs Your TMF “Fit”?
Effectively Operationalizing your Trial Master File Requires the human element. Like so many of you, I really love my Fit Bit. Nothing gives me more satisfaction then to see the counter turn to 10,000 each and every day. Unfortunately, the counter does not turn by itself. In order to reach my 10,000 step-a-day goal, I…
Read MoreCEOCFO Interviews: Sholeh Ehdaivand
May 11, 2015, Lynn Fosse, Senior Editor, CEOCFO Magazine – CEOCFO: Ms. Ehdaivand, what is the focus at LMK Clinical Research Consulting today? Ms. Ehdaivand: Our focus at LMK is to operationalize the Trial Master File for the Life Sciences Industry. We are exclusively focused on Trial Master File (TMF) management and we offer comprehensive…
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