Press Releases

LMK Clinical Research Consulting Ranked 4th Fastest Growing Business in the Booming Charlotte Economic Region

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 in the 16-county Charlotte region.  Through a highly selective process, honorees are ranked by their total gross revenue growth over a three-year period, between 2014... Read More

When Medicines Go On Trial, LMK Makes Sure They Get It Right

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 involved in clinical research for over 15 years and I was astounded to see the number of life sciences companies that were denied regulatory approval... Read More

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

22 May 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 “LMK Complete,” an eTMF agnostic process to determine TMF completeness to support regulatory inspection readiness. Performing TMF Quality Control (QC) and determining which documents are expected throughout the course of a clinical trial can be a daunting, resource draining process for most life sciences organizations.  LMK Complete is a comprehensive TMF QC... Read More

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

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 to provide TMF training to an institution of higher learning. In partnership with the University of North Carolina Wilmington, LMK’s TMF University will generate customized... Read More

LMK Clinical Research Consulting: Sustainable Processes for Clinical Trial Quality

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 of her career to mastering clinical trials, TMF subject matter and management, ultimately founding LMK Clinical Research Consulting in 2013. “We are a group of... Read More

Leading Trial Master File Consulting and Services Provider Also Recognized as Industry Innovator

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 Business are the world’s top honors for female entrepreneurs, executives, employees and the organizations they run.  All individuals and organizations worldwide are eligible to submit... Read More

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 standards of GCP and with all applicable regulatory requirements.” (ICH E6 Good Clinical Practice, Section 8.1) A sponsor auditor or regulatory (i.e., government) inspector uses... Read More

Company 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 at any time before, during and after the trial has been concluded. A Trial Master File (TMF) is the main set of these documents and... Read More

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 trial, yet many companies have a difficult time keeping up with the ever-changing regulations, processes and technology,” said Shahrzad Slater, MD, MPH, Senior Vice President... Read More