LMK Clinical Research Consulting considers the TMF to be the foundation of clinical trials, we follow established processes to attain the highest TMF quality. A quality TMF is the fundamental goal of every clinical trial and critical to its success as it is the tool used to demonstrate compliance of a trial, and it allows for verification of the integrity of the trial data and patient safety. The TMF is the only tangible product at the conclusion of a study; therefore, it should be inspection ready at all times.
LMK Complete is an innovative eTMF agnostic process that can be utilized across any organization regardless of the TMF format (electronic, paper or hybrid). After reviewing your document repository and file process, our team of experts creates a customized process that addresses your needs.
The TMF must contain all documents that permit the evaluation of study conduct and data quality. If your TMF is not up-to-date or quality controlled performed on an ongoing basis—no problem—we can help. Our qualified team performs file remediation to identify potential quality gaps and creates a customized action plan for correcting these discrepancies.
Dedicated 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. 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:
- Identifies and documents true discrepancies and potential gaps within the TMF. Resolves discrepancies rather than generating a long list of queries for your team to resolve.
- Ensures your TMF is inspection ready at all times throughout the study through routine TMF QC - providing you with another level of validation.
- Reduce costs and expedites timelines through "efficient" TMF content QC and remediation.
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.