Sholeh Ehdaivand, President & CEO
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 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 professionals who have come together on the belief that the TMF is the most important deliverable of a clinical trial and everything that we do stems from that certainty,” says Sholeh, Principal Consultant, CEO and President of LMK Clinical Research Consulting. “If a clinical trial is a ‘daisy’, the TMF is the eye and everything stems from the eye of the daisy.”
LMK’s goal is to provide clients with not only high quality TMF services, but to also educate them about the importance of the TMF within a clinical trial. Sholeh’s emphasis is on providing their clients with quality people and a sustainable process—the twin factors for a solid TMF foundation. “The process doesn’t necessarily revolve around the technology,” says Sholeh. Being technologically agnostic, LMK focuses on the process and the people, who have perfect understanding of clinical trials and quality to help their clients plan, collect and maintain their clinical trial documents.
“It is important for us to educate our clients about the TMF from the process standpoint and not the technology standpoint,” delineates Sholeh. LMK’s TMF University—a collection of module-based TMF learning courses, educates clients about everything from regulations to TMF quality.
If a clinical trial is a ‘daisy’, the TMF is the eye and everything stems from the eye of the daisy
“Our goal is to help our clients understand why the TMF is important and how it should be managed.”
Aside from clients, employee education is paramount at LMK. Being involved with various client types, from large pharmaceutical companies to small biotech firms, LMK employees need to understand the challenges faced by their clients and, use an appropriate approach when dealing with their TMF needs in order to assure a high-quality service. LMK’s consultants are equipped with the required know-how to provide adequate support and ensure that all documents are inspection-ready.
Ultimately, the objective of LMK is to provide their customer’s with an accurate TMF for success during a regulatory inspection. According to Sholeh, one of the challenges they [clients] face is in ensuring TMF documents are collected and filed within a given deadline. Consequently, Sholeh mentions the appropriate solution, “We created a process for collecting the documents which ensures the documents from the various functions are collected and filed in a timely manner. We also review the TMF for completeness. If there are missing documents, we remediate immediately.” Finally, what benefits the client in the end is a complete TMF, with all documents filed appropriately and diligently according to the milestone and event which occurred during the trial.
LMK stands unique in clinical research consulting through its combination of TMF expertise and extensive knowledge of the clinical drug development process. Sholeh concluded, “by improving the quality of the TMF during trials, we believe that the world will be introduced to medications and medical devices in a timely manner that could potentially save many lives.”