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What Is Etmf: An Introduction To Octalsoft’s Etmf Solution

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By Author: Octalsoft
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A content management system used to capture, organize, exchange, and retain operational and study information, known as an electronic trial master file (eTMF), has become an essential tool in current clinical research operations. Good Clinical Practice (GCP) guidelines necessitate a trial master file for the review of trial conduct.

Fully integrated eTMF system

At Octalsoft, we consider trial master file technology to be an integral component of the data collecting and study management experience, which can be readily integrated into your existing workflow.

But what does this imply for users, and why is it advantageous? To begin, it consolidates all papers into a single location, saving you the time you'd otherwise spend hunting for what you're looking for. Instead of storing critical papers in two or three distinct databases, a platform like Octalsoft’s eTMF can collect and store them alongside study data.

Furthermore, structured data from EDC or ePRO can be saved straight to eTMF inside the same platform. When setting the study, Octalsoft allows study builders to map any provided form to eTMF. ...
... All of this adds to a cleaner and easier audit trail, which reduces the burdens associated with inspection time.

Granular management of documents and their associated tasks

Octalsoft’s eTMF is very adjustable and flexible, much like the rest of the Octalsoft platform (EDC and eSource, ePRO/eCOA, eConsent, CTMS, RTSM, and so on). It was thoughtfully designed to enable research experts' capacity to truly micromanage data and documents, as well as the duties related to them, in an ultra-efficient manner. The folder structure and hierarchy can be customized to meet the needs of the host or the study, and folders and their contents can be simply copied for quick reproduction.

Account administrators can also control who has access to different components of eTMF. For example, you could offer users access at a granular level (file per file), or you might grant access to all files.

Our goal was to create an eTMF that adapts to our clients' studies rather than forcing studies to adapt to eTMF, and we're thrilled to offer a solution that does just that.


In summation

Octalsoft's eTMF software solution provides a digital platform and strategy for electronically capturing, organizing, sharing, and storing all critical documents, photos, and artifacts that develop over the course of a regulated clinical trial. The system includes the DIA TMF Reference Model, which enables users to organize their content according to a known taxonomy and structure. Built-in checklists and milestone tracking capabilities enable you to actively assess the completeness and compliance of any material in real time.

Learn even more about Octalsoft eTMF here. Do you have questions or are curious about how to leverage it in your studies? Book a Demo with us today!

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