EVERYTHING IN ITS PLACE
Ensures an overview of all essential and other documents required by GCP for your studies
Our eTMF for all needs
The AMEDON 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 taken 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 and structure. In doing so, you are independent of whether it is a study in the field of medical devices, medicinal products, a combination or a study according to professional law. In addition, you can depict monocentric as well as multinational, multicentre studies. This is ensured by profile sets that can be freely created and combined with each other as desired on the one hand and a free creation of the protocol and trial centre structure on the other.
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 that always meets your needs. In addition, an interactive and printable content file is included, showing the individual documents, their revisions and their 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 centres for their ISF. It is possible at any time to export the ISF documents stored in the application for each centre involved in a study in a structure predefined similarly to the TMF. This ensures that only your reviewed versions of the documents provided are also included in the ISF.
Overview and structured processes
Within a study, it is possible to make tailored workspaces accessible to different groups of users and to assign associated privileges. To this end, simple processes are also deliberately kept simple on the user interface. This avoids frustration and increases compliance. For example, you can give centre staff access to upload CVs etc. even with minimal training. This allows you to receive documents quickly and securely and also avoids redundant efforts.
We offer a fair price model, regardless of whether you manage only one monocentre study in eTMF or many multicentre studies at the same time.
Welches Thema interessiert Sie?
CDMS SAE Reporting Labordaten CDISC Designer Randomisierung Medical Device Payments Supply Management Imaging Medication Handling Second Opinion Review Interface E2B Data Cleaning Queries EventNotification Amendment Diary Questionnaire eCOA App Smartphone BYOD NRS/VAS/VRS Study Management Milestones Contact Management Monitoring Reporting TMF Overview Essential Documents Staff Auswertung KPI Risikomanagement RPI Controlling Data Mining Dashboard Report Standardisierung 21 CFR Part 11 Notfallmanagement Patientendaten in klinischen Studien