Because 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.
Quality Control Tool
Identifying and resolving TMF issues can be challenging and time consuming. To facilitate this process, our experts utilize a customized quality control (QC) tool to perform our QC – say goodbye to spreadsheets! Our QC tool helps ensure a complete, consistent TMF by identifying potential gaps and discrepancies in your processes. If issues are identified, our qualified team provides support to correct the discrepancies.
Our QC process is sustainable and can be easily followed by all TMF contributors. 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.