Hello From Sholeh Ehdaivand
Welcome, and thank you for taking the time to explore the LMK Clinical Research Consulting website. At LMK, we are a unique company built on the principle that the Trial Master File (TMF) is the foundation of every clinical trial. Looking at how a foundation is constructed, there are deep foundations (experienced resources and well defined processes) or shallow foundations (outsourcing without controls and lack of established processes). In order to have an inspection-ready foundation regardless of its depth, a strong construction is imperative.
At LMK, we believe that constructing a strong TMF foundation is a simple equation consisting of two very important ingredients: PEOPLE + PROCESS
1. People includes all TMF stakeholders (contributors, owners, QCers, scanners, or indexers).
2. Process includes Standard Operating Procedures, content standards, content collection, and quality control/assurance.
Over the last several years, we have seen the an evolution of the TMF from dusty banker’s boxes to sophisticated electronic systems that are rapidly changing the way that we manage our clinical trials. Along with the sophistication of the technology, there also needs to be growth and development of the people utilizing and managing that technology -which is high priority to LMK - and established sustainable processes that are built on the quality.
Our Professional Development Services provide TMF training from novice users all the way through to highly skilled clinical research professionals who are wanting to increase their team’s knowledge base. We offer a unique training program, TMF University, designed in individual modules to meet your TMF needs.
We also offer provisional TMF resources through our innovative resourcing model - TherAlign™ - functionally aligned resources with specialities ranging from Clinical Operations to Regulatory Affairs and everything in between.
In addition to aligning the right people, we recognize that sustainable, proven processes are essential to building a strong TMF foundation. As an eTMF agonistic company, we appreciate that no two companies’ needs are the same. From Standard Operating Procedure development through TMF archival, our processes offer our clients superior results. A well-developed TMF process can only be developed by resources that understand that the TMF is one of the most important outputs of a clinical trial.
I welcome the opportunity to discuss your TMF needs!
Sholeh Ehdaivand, President and CEO | Sholeh.Ehdaivand@lmkclinicalresearch.com | 1-919-730-4855