The TMF Professionals
Two words that can ignite worry, fear, and stress. At LMK, we work with our clients to alleviate those concerns and ensure that you are inspection ready from Day One. We believe that clinical documentation is the foundation of every clinical trial, and a strong foundation is key to the overall health and stability of any clinical program. LMK takes a proactive approach and makes clinical trial content quality a top priority on an ongoing basis – from start through closeout – not just pending an inspection or trial completion.
LMK Clinical Research Consulting is a family of TMF experts united by extensive knowledge of clinical trial operations, clinical documentation management, and a desire to help others achieve TMF success. LMK’s experienced TMF consultants and project managers have decades of combined experience in the following core competencies:
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.
eTMF Selection And Implementation
Change is good. Whether transitioning from paper to electronic TMF, or between two eTMF systems, 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. Don’t let the fear of change hold your organization back. LMK’s team of experts empower your team to turn TMF drudgery into TMF mastery—transforming your TMF into a competitive advantage.
TMF Reference Model Implementation
As TMF Reference Model SMEs, LMK’s TMF experts specialize in indexing your organization’s documents with the TMF Reference Model. LMK is ready to develop, in consultation with your team, a complete TMF ‘table of contents’, harmonizing document expectations across your clinical documentation team.
Document Filing and Indexing
LMK’s TMF experts allow for unprecedented flexibility when it comes to conquering document management challenges. Our TMF experts quickly pivot in response to changing document management resource needs, eliminating document handling latency, and ensuring your TMF is inspection ready upon close out.
Document Quality Control
LMK’s TMF analysts are ready to adapt to the specific needs of your trial. Our TMF analysts can verify the individual document quality of a percentage of your documents or review every document in your TMF. LMK’s TMF analysts are prepared to QC documents to your exacting standards and are trained to consider a macroscopic view of a trial — even when reviewing the fine details.
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.
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.
Interested in Learning More? Contact our TMF Professionals
Designed for Real-World Implementation
LMK’s TMF University program offers a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise. TMF University allows your entire team to benefit from the collective experience of LMK’s TMF experts and may even inspire your team to take a new perspective on the TMF.
Of course, the TMF plan, QC plan, and your regulatory strategy all depend on the foundation provided by a functional QC cycle. Regardless of your experience, TMF University and our TMF experts will guide your team towards the implementation of a QC cycle that continually verifies the condition of the TMF against the expectations captured in your TMF plan. Not just a simple list of documents, the output of your TMF QC cycle will be a focused and actionable path to success.
Take the Next Step with LMK
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.
Why Choose LMK
Elite TMF Review Team
With expertise in clinical trials and TMF management, the ETRT reviews your TMF content in a timely manner using an established process and tool to perform TMF QC that highlights gaps and discrepancies within the TMF.
By utilizing LMK’s ETRT, you benefit from increased process efficiency and TMF compliance – saving you time and reducing your costs while increasing the quality of your TMF
TMF Quality Control
LMK Complete ensures that the TMF as a whole is complete, accurate, and inspection ready at all times. LMK Complete is a TMF QC process that can be followed by all Functional Lines regardless of the type of content that is or has been filed.
Ensuring TMF quality is the single most important deliverable of a clinical trial. Given the current attention to the TMF, regulatory agencies can show up at any time to review the content. Don’t be caught off guard. Make sure your trial is ready by having the leaders in TMF management at LMK provide our proven TMF QC processes.