Product Overview
Deploy a highly effective eTMF solution to electronically capture, organize, share, and store all those essential documents, images, and artifacts that arise during the lifecycle of a regulated clinical trial. Now organize your content in a recognized taxonomy and structure with built-in checklists and milestone tracking features.
Access a flexible wizard-driven process for setting up eTMF – table of contents (TOI), document templates, metadata, and other parameters, allows the user to accurately customize the TMF filing plan with study-specific documents. The plan once configured can be further saved as a reusable template.
TMF Reference Model
The TMF reference model provides standardized taxonomy and outlines a reference definition of TMF content using industry-defined nomenclature. Adherence to the TMF reference model brings order, structure, and lineage to your eTMF – helping you segment and organize data efficiently.
Optimized Search and Retrieval
The Octalsoft eTMF solution leverages the metadata related to your document to help locate the relevant document in a search, even find the content within the artifact. Our experienced team helps you to associate custom metadata fields to fit with your process and study parameters.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
Octalsoft eTMF allows you to define user roles and customize them to your specific process. Each user will have just enough access to the data/document that is required by him to perform his delegated function. Ours is a solution with granular permissions will allow you to set access levels for various functions.
Customizable User Roles
Octalsoft eTMF provides multi-layered security across databases and applications to maintain the integrity and confidentiality of the data. It implements data encryption, authorized access controls, usage analysis, log history, and conditional auditing to meet compliance requirements.
Highly Secure
Octalsoft eTMF software provides timely and relevant alerts and notifications to users to action or complete tasks within the system. Having a contextual, rule-based notification system, based on user roles, significantly reduces the time which is otherwise required for cross-functional communication.
About the company
Octalsoft is a market leader in the field of eclinical solutions, IT consulting, custom software development, app development, digital transformation, and technology consulting. Established in 2007, Octalsoft sports over a decade of experience and a team of 60+ experts who have delivered consistent success with over 30000 platform users and a clientele spread across 22 countries. Here is glimpse of how we reached where we are today.