Latest News – Press Releases

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

LMK 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 resources is greater than ever. TMF University was created to respond to the growing need to develop highly skilled TMF personnel.  TMF University provides comprehensive training based... Read More

Halloran Consulting Group Partners with LMK Clinical Research Consulting to Enhance Clinical Trial Master File Management and Process Planning

January, 20 2016 - Boston, MA (PRWeb) - 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, biotechnology, and clinical trial sites across the U.S. Trial Master File (TMF) documents are critical in supporting compliance with clinical trial regulations and... Read More

LMK 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 office, Dr. Slater will oversee LMK’s TMF Services Group (consultants and resources); Strategic Analysis and Quality TMF Programs (TMF QC and mock inspection services); and... Read More