LMK News

Huntersville, NC –April 24, 2018– LMK Clinical Research Consulting, a Trial Master File (TMF) consulting firm committed to the future of clinical research by revolutionizing the TMF, has announced the launch of LMK Ready, an industry-first flexible TMF consulting service. LMK Ready provides the expertise necessary to overcome your TMF challenges, whether TMF process and…

“Just write a memo to file.” How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself? A memo to file (MTF) is a document filed in the trial master file (TMF) that is intended to…

Introduction The release of the 2017 ICH GCP E6(R2) guidelines marks a paradigm shift in clinical research. Risk is mentioned no fewer than 30 times in the guidance. ICH GCP E6(R2) section 5.1 requires that the sponsor of a trial, “implements and maintains systems for quality assurance and quality and control.” 1 The EMA recognizes, that although…

Charlotte, NC – December 12, 2017 – LMK Clinical Research Consulting has been selected as one of the fastest growing companies in the Charlotte region according to the 2017 Fast 50 Awards hosted by the Charlotte Business Journal. The Fast 50 Awards honor independent and privately-held companies with revenues of $1 million or more, based…

SUPPLIER DIVERSITY – WBENC CERTIFIED Editorial Sponsored by Bristol-Myers Squibb By Arthur Schurr Bringing a medicine to market is not easy. It takes time. It takes money. It takes research. But it also takes something else that is surprisingly often overlooked—documentation. And that’s exactly why Sholeh Ehdaivand founded LMK Clinical Research Consulting (LMK). “I had been…

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,…

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…

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…