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avatar for Sholeh Ehdaivand

Sholeh Ehdaivand

LMK Clinical Research Consulting
President and CEO
Sholeh is an internationally known TMF Subject Matter Expert with over 20 years of experience in the Clinical Research Industry.  Her expertise and knowledge in all areas of study management, clinical trial operations and TMF document management processes have made her a leader and trusted expert in the field. Her experience includes: TMF Reference Model Subject Matter Expert, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations, electronic document management, regulatory submissions, quality control processes and implementation, and regulatory inspection preparation and participation.
The Founder, President and CEO of LMK Clinical Research Consulting, Sholeh is also the Facilitator for the Metrics Champion Consortium’s (MCC) TMF Initiative.  In this role, she is leading a group of cross-functional experts in the development and implementation of TMF metrics and processes.  When Sholeh is not busy with LMK, she is active in her community where she actively participates in charitable organizations, including Make-A-Wish, Junior League of Charlotte, and Jack and Jill of America.
LMK Clinical Research Consulting provides expert solutions and services for TMF document management to the life sciences industry.  The company’s foundation is built on the belief that the Trial Master File is the foundation of every clinical trial, and that a strong foundation is key to the overall health and stability of any clinical program.  LMK offers a comprehensive portfolio of services that support TMF health and inspection readiness, including TMF implementation, review and remediation, quality control processes, audit and inspection preparation and support, development of workflow processes, and customized training and consulting.
LMK is certified as a woman-owned business by the Women’s Business Enterprise National Council (WBENC) and the Small Business Administration (WOSB), and is certified as a Minority Business Enterprise (MBE) by the Minority Supplier Development Council. For the past two consecutive years, LMK has been ranked nationally as one of America’s Fastest Growing Private Companies by Inc. 5000.