eTMF Software Systems

An electronic trial master file (eTMF) software system minimizes the burden, risk and complexity of managing vast amounts of clinical trial data by automating, centralizing and standardizing the TMF process.

A trial master file (TMF) contains essential documents and artifacts associated with a clinical trial which are subject to compliance with ICH GCP, FDA 21 CFR Part 11 and other regulatory requirements. The TMF must not only contain adequate and accurate data, but it must also be organized in a manner suitable for evaluation by inspectors, and sharing with clinical study team members both internally and externally. MasterControl goes beyond mere document management by providing an eTMF software system based on the TMF Reference Model that is designed to enable real-time visibility into the status of all activities pertaining to a clinical study.

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