Is your TMF inspection ready?

From study start through completion, our TMF experts offer a comprehensive portfolio of document management solutions to help you develop, plan and implement processes that will engage stakeholders and mitigate risks. Our expert oversight will enable you to effectively manage progress and plans while avoiding the most common areasof non-compliance.

Our Services

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TMF Quality Control

Our experts are ready to help you implement a cycle of QC that continuously verifies the condition of your TMF against your team’s TMF expectations. 

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Document Filing and Indexing

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eTMF Selection And Implementation

LMK’s team of experienced experts are ready to ensure an orderly transition and provide a stable foundation of polished eTMF processes to provide clarity for your team. 

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SOP and Process Development

Our experienced team offers custom solutions tailored to  your business through the development of meaningful SOPs, work instructions, and processes.

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TMF Reference Model Implementation

LMK’s TMF experts specialize in indexing your  documents with the TMF Reference Model. LMK is ready to develop a complete TMF ‘table of contents’.

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TMF University

From Custom to Novice to Advanced, our full suite of TMF training modules can provide a foundational understanding of the TMF.

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our Leadership team

Sholeh Ehdaivand

President &
CEO

Sholeh is a facilitator of the Metric Champion Consortium’s TMF initiative; a cross-industry group defining standard metrics and key risk indicators that support the TMF. Her 15 years of experience and knowledge in study management, the operational aspects of the clinical trial, and document management have made her a  trusted expert. 

SHAHRZAD SLATER

SENIOR VP OF CLINICAL OPERATIONS

Dr. Slater is an innovative and energetic professional with over 13 years of clinical and management experience. Recognized as a motivated, flexible, and team-oriented leader, she oversees all clinical operations at LMK. Dr. Slater is a proactive & results driven leader with a proven record of successfully seeing projects to completion.

JACKIE MORRILL

EXECUTIVE DIRECTOR OF CLINICAL OPERATIONS

Jackie is a Lean Six Sigma Green Belt certified clinical research professional with over a decade of experience. Her experience includes oversight of eTMF implementation, coordination of migration projects, development of training programs, and inspection readiness preparation for FDA, MHRA, and PDMA inspections.


Working hours

Monday - Friday: 8:00 AM - 5:00 PM
(Phone until 6:00 PM)

We are here

9815 Sam Furr Rd, Huntersville, NC 28078
Phone: 704-464-3291
Email: hello@lmkcrc.com

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