We exist to simplify the documentation of clinical research to accelerate new health solutions for humanity.

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The TMF Professionals

LMK Clinical Research Consulting is a leader in Trial Master File (TMF) document management services and solutions for the life sciences industry.

Inspection Readiness

Our experts can support your TMF strategies in numerous ways, learn more.

TMF Functional Service Provider

Functional Service Provider

Reduce resource burdens and increase quality by taking an “a-la-carte” approach – outsourcing only what you need to help manage your clinical trial content.
TMF Essentials - Document Quality Control

Document Quality Control

Ensure superior document QC standards by using expert QC services for some or all of your TMF documents and files.
TMF Quality Control

TMF Quality Control

Implement a cycle of Quality Control that continuously monitors the condition of your TMF.
SOP & Process Development for the Trial Master File

SOP & Process Development

Develop a foundation of sustainable SOPs, work instructions, and processes to ensure that your TMF can be complete, accurate, and inspection ready at all times.
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eTMF Implementation

Ensure an efficient and orderly transition with expert guidance and a stable foundation of detailed processes, whether moving from paper or migrating between eTMF systems. Our team supports seamless implementation tailored to your workflows and designed to enable long-term compliance and usability.
TMF Reference Model Implementation

TMF Reference Model Implementation

Establish clear expectations among all stakeholders with accurate indexing of documents within the TMF Reference Model framework.
Trial Master File Document Filing & Indexing

Document Filing &
Indexing

Eliminate document handling latency by engaging LMK's team of TMF professionals to ensure your TMF is inspection ready upon closeout.
TMF Training & Stakeholder Engagement

Training & Stakeholder
Engagement

Training and Stakeholder Engagement are the cornerstones of every optimally functioning TMF department. Our TMF Professionals can help you reinvigorate your team's approach to managing every Trial Master File.
Metrics Driven Process Improvement for the Trial Master File

Metrics Driven Process
Improvement

Develop metrics (per Metrics Champion Consortium guidelines) to assess the completeness and quality of your TMF on an ongoing basis.
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TMF Rescue

When TMF challenges arise, you’re not alone. LMK's experts turn your concerns into confidence. We conduct a thorough gap analysis to pinpoint areas of concern, then tailor a remediation plan to bring your Trial Master File up to regulatory standards. Our strict quality control checks ensure every detail is accounted for. Plus, with our proactive training, your team will be empowered to maintain TMF excellence.

Our experts can support your TMF strategies in numerous ways, learn more.

At LMK, we strive to make our clients better for the future – removing the burden of Trial Master File management with calm, empathetic confidence and a positive mindset.

What Our Clients Have to Say

You will never work with a better partner than LMK. They are not the kind of partner who solely solves your problems; rather, they teach you how to solve future issues and help you to think critically about your project. Not only are they extremely knowledgeable, but everyone at LMK was helpful, friendly, and approachable. If you have the opportunity to work with LMK, pull the trigger in a heartbeat!

JULIE
MEDLINE INDUSTRIES, INC

We would be dead in the water without LMK. They really know what we’re trying to achieve and our priorities.

CURRENT LMK CLIENT

There will always be bumps in the road, but LMK always has our best interest at heart and always puts that at the forefront of what they do.

CURRENT LMK CLIENT

Over the years, the collaboration with LMK has been very positive. LMK offers a large range of specialized TMF services that can be customized to fit your needs. One very important part of the collaboration is the open and direct dialogue in all circumstances.

MARIE-CHRISTINE
FORMER HEAD OF TMF AT PFIZER