eTMF
Our eTMF for all needs
The AMEDON electronic trial master file (eTMF) supports you in receiving, allocating and tracking essential and other study documents, e.g. according to the TMF reference model of the DIA. Users can provide, file and review documents within the responsibilities defined by you.
One application for all your studies
Our eTMF application supports the administration of any number of studies. Benefit from reusable profile templates according to standards such as the DIA reference model and your established TMF structures when setting up each new study. The circle of users can also be transferred from existing studies or be completely independent of them.
Any study type can be maintained
Within the eTMF application it is possible to represent any study type (medical devices, medicinal products, combinations) and structure (monocentric, multicentric). This is ensured by profile sets that can be freely created and combined with each other as desired.
TMF and ISF
It is possible to create and download a TMF document package at any time. The package contains all documents and their revisions in a freely definable folder structure. In addition, an interactive and printable content file is included, showing the individual documents, their revisions and status.
The eTMF application takes advantage of the fact that a large part of the documents to be maintained in the TMF are identical to the documents provided to the trial centers for their investigator site file (ISF). Any time, it is possible to export the ISF documents stored in the application for each center involved in a study in a predefined structure similar to the TMF. This ensures that also reviewed versions of the documents provided are included in the ISF.
Overview and structured processes
Within a study, it is possible to set up tailored workspaces for different user groups with associated specific privileges. To avoid frustration and increase compliance, processes are kept simple on the user interface. For example, you can give center staff access to upload CVs etc. with minimal training. This allows you to receive documents quickly and securely and also avoids redundant efforts.
We would be happy to answer your questions about our services personally.