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The LMK Advantage – Services with Distinction

We are TMF experts with extensive knowledge in clinical trial drug development and TMF document management services. Our premier service, LMK Complete, operates throughout the life cycle of our clients’ product’s to effectively plan, collect, and manage their clinical trial documents on an ongoing basis. With LMK’s TherAlign™ system, our team provides guidance as subject matter experts, ensuring TMF compliance and providing unmatched quality deliverables. Finally, our team performs TMF Quality Control and remediation across Functional Lines, ensuring TMF accuracy, and providing additional TMF support during an audit inspection. 

Times are changing now more than ever. We provide the document management tools that help our client’s make smarter decisions and gain the competitive advantage.

Our Services

Customized TMF Solutions

We are an eTMF agnostic company and are fully trained in all of the major eTMF technologies. If you need to streamline your TMF process and want to have your TMF content in one electronic repository, we can help. Our experienced resources will migrate your TMF content quickly and efficiently ensuring instant access to your trial content

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LMK Complete

LMK Complete Is A Strategic, Step-By-Step Process That Ensures Inspection Readiness For Your TMF. Our TMF Experts Will Initiate A Quality Control (QC) Plan And Create A Customized TMF QC Checklist To Ensure All Required Documents Are Available. After A Review, We Will Take Inventory Of Your TMF And Contrast It To Your Expectations. We Will Also Review The Inventory For Any Documents That Require Remediation. We Will Continue Remediation Efforts Until All Findings Are Resolved, And Track Resolutions Per The QC Plan. We Continuously Review All Ongoing Work And Maintain Communications To Ensure Quality And To Gauge Progress, While Swiftly Resolving Any Issues That Arise. Completion Results In Providing A QC Summary And Certification Of Inspection Readiness.

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TMF University

Our Unique Training Program Is Designed In Individual Modules Which Allows You To Select Only What You Need. Your Individual Training Program Can Be Customized With Modules From The Different Experience Levels. TMF University Can Provide The Foundational Knowledge Required To Understand The TMF.

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Take the Next Step

Schedule a complimentary consultation with our team

LMK Clinical Research Consulting can perform a true TMF QC review based on what types of documents you expect to see in the TMF, not just on an inventory list of what’s present. We will ensure that your TMF is complete, accurate, and inspection ready at all times.

With careful planning, an agreed level of quality, proper equipment, verification, continued inspection, and corrective action, you can be assured your TMF is of high quality and will be treated as such at LMK Clinical Research Consulting.

Our TMF professionals are ready to meet with your team and discuss how we can help bring the LMK Advantage to you. 

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