An Advanced Electronic Trial Master File (eTMF) Solution
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Montrium’s proven eTMF Connect solution helps life sciences companies better manage their clinical trial documentation. It has been designed using the TMF Reference Model, and centralizes and standardizes your clinical records enabling both sponsors and CRO’s to contribute and access important clinical documents and information in real-time. eTMF Connect allows life sciences organizations to manage all of the essential documents required to be included in the Trial Master File/eTMF.
Our solution can also be configured to allow direct access to inspectors after minimal training. eTMF Connect combines comprehensive clinical eTMF functionality, advanced collaboration features, and complete scalability to create a dynamic, intuitive and powerful eTMF solution that provides unparalleled customer benefits and value.
There are many factors which are motivating the pharmaceutical industry to move towards electronic Trial Master Files (eTMF). The compilation of the TMF can be one of the most challenging activities within a clinical trial, with thousands of different documents and records that need to be produced and organized. These records often come from many different organizations, and with increased outsourcing and more global clinical trials, the compilation of the trial master file in a timely manner is becoming increasingly burdensome.
Montrium recognizes that the TMF holds a significant wealth of information which is of strategic importance for the successful conduct and reporting of clinical trials. We have leveraged our in-depth knowledge of clinical processes and the TMF Reference model to design an eTMF tool which is at the heart of the clinical trial.