We make sure that all electronic trial master files (eTMFs) are DIA TMF formatted and accessible to you and trial monitors through a secure portal that’s managed by our experienced eTMF personnel. Quality, completeness, and timing metrics are built into the system for inspection-ready files.
We update our system structure with the latest CDISC TMF Reference Model recommendations annually.
We give each study its own eTMF plan outlining required documents and processes.
Access for your team members, inspectors, and monitors can be defined and selected for the appropriate level of security.
We make sure metrics outlining the quality of documents, timing of submissions, and file completeness are dashboard standards in your eTMF.
Documents are collected and filed by experienced eTMF personnel, trained in the DIA model and GCP regulations.
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