Services

The LMK Advantage

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

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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Ther-Align™ is a unique resourcing solution which aligns TMF experts by therapeutic area (examples: oncology, infectious disease) and/or functional line (examples: clinical operations, data management). Experts selected for TherAlign™ previously served as clinical research associates, data managers, and other positions in clinical. This widened experience base enables the Expert assigned to your TMF to exercise clearer, more objective insights - from YOUR perspective as well as that of the TMF Reference Model. In short, their experience with specific areas enables them to focus on specific needs of the TMF - which will thereby focus on your TMF being inspection-ready sooner. This will benefit you in the following ways:

• Clarifies concise expectations of your TMF content;

• Heightens quality of your document management, which ensures that only correct documents will be posted;

• Reduces remediation, thereby reducing overall time of review of the TMF.

 

In summary, TherAlign™ will significantly reduce review time by focusing efforts based on specific needs, thus saving you time and money. In future, this can also contribute to streamlining review processes and ensuring a continuing review process to keep your TMF ready for inspection.  

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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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We are an eTMF agnostic company and are fullly 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.

We ensure the documentation filed meets quality criteria throughout the life of the clinical trial. We can also create a customized process for collecting documents from Functional Lines, clinical sites, and CROs (if applicable) from study start through study completion.

Our team ensures that the TMF as a whole is complete, accurate, and inspection ready at all times. Our proven TMF QC process can be followed by all Functional Lines regardless of the type of content that has been filed.

We perform final TMF QC and remediation ensuring that all discrepancies have been resolved and the TMF is properly closed and archived (paper, eTMF system or hybrid).