The TMF Professionals
LMK Clinical Research Consulting is an industry leader. We provide expert knowledge and experience in TMF and quality document management.
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Quality Document Management
LMK can help you plan, collect, and maintain your clinical trial content cost effectively without jeopardizing quality. Our experts will assess your study requirements and processes and create a plan customized to meet your specific needs.
Our Services

At LMK, we believe the Trial Master File (TMF) is the foundation of every clinical trial, and a strong foundation is key to the overall health and stability of any clinical program. That is why LMK takes a proactive approach and makes TMF quality a top priority on an ongoing basis – from start through closeout – not just pending an inspection or completion. Don’t let your TMF be a document collection burden at the end of a trial! It is a management tool throughout the life of your trial. LMK can help you plan, collect, and maintain your clinical trial content cost effectively without jeopardizing quality.

 

Our Mission

Simplify the documentation of clinical research to accelerate new health solutions for humanity.

Services with Distinction

Our goal is to serve our clients with dignity and provide them with the highest quality services available to assist with making sure their TMF is always ready for inspection.
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What We Do

SOP and Process Development

LMK’s TMF experts know that your TMF can be complete, accurate, and inspection ready at all times with a foundation of sustainable SOPs, work instructions, and processes. Our experienced team offers custom and comprehensive solutions tailored to the specific needs of your business through the development of meaningful SOPs that ensure the System of Record for all your content is complete and accurate.

TMF Quality Control

LMK’s TMF 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. Our TMF consultants have the decades of experience necessary to reignite document stakeholder engagement and to resolve TMF risks and deficiencies.

Inspection Readiness

LMK’s TMF experts have years of experience developing compliance-based TMF expectations that fit an organization’s unique goals. A Mock TMF Inspection is your most powerful tool to evaluate the story held in your TMF and control regulatory risk.

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Quality TMF Services

LMK takes a proactive approach and makes TMF quality a top priority on an ongoing basis – from start through closeout – not just pending an inspection or completion. Don’t let your TMF be a document collection burden at the end of a trial.

Elite TMF Review Team

The Elite TMF Review Team (ETRT) is a dedicated team who performs TMF QC and remediation (if needed) for risk-based or 100% of the content within the TMF. The ETRT has experience in paper, electronic, and hybrid TMFs and is available to assist you onsite or remotely.

TMF University

Our unique TMF training program is designed in individual modules that can be mixed and matched among the different experience levels. Our instructors provide quality instruction and guidance to improve your entire TMF operation.

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