Customized TMF Solutions
We can develop SOPs to ensure the System of Record for all content is complete and accurate. As TMF Reference Model SMEs, we can facilitate and support organizational implementation. We review the TMF RM by zone to determine which documents are applicable, create a master reference document for use by the entire company, ensure a complete and thorough master list of possible content to file in the TMF.
Our unique training program is designed for all levels from novice learners to experts covering a range of TMF topics in 16 modules, from document recognition training to TMF quality control processes. TMF University can provide the foundational knowledge required to understand the TMF.
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.
TMF Quality Control
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).