A Complete eTMF Platform Engineered for Growth Organizations
Take a video tour of eTMF Connect
Montrium’s proven electronic trial master file solution eTMF Connect helps life sciences companies better manage their clinical trial documentation. Designed using the TMF Reference Model, eTMF Connect centralizes and standardizes your clinical records enabling both sponsors and CROs 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.
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.
Simplify your clinical environment
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. Using in-depth knowledge of clinical processes and the TMF Reference Model, the eTMF Connect software tool has been designed for users like you working at the heart of the clinical trial.
- Pharmaceutical Organizations
- Contract Research Organizations
- Academic Research Organizations
- Facilitate exchange of clinical trial information to all stakeholders
- Accurately track the progress of TMF completeness
- Quickly comply with regulatory requirements, audits and inspections
Take the tour
Real-Time TMF Completeness Reporting
Real-time eTMF Completeness
With the eTMF Navigator, you can get a visual view on real-time completeness based on study, country and site milestones
Powerful Business Intelligence
Apply filters and different dimensions to intuitively navigate through the eTMF
Real-time Artifact Status
Artifact Status is displayed in a visually recognizable way. You can easily see where documents are complete, expected or missing by process zone and section.
Interactive viewing and authoring
You can easily view TMF artifacts, view metadata or directly upload missing documents directly from the eTMF Navigator.
Centrally Manage your Clinical Documentation
Preconfigured TMF Structure
eTMF Connect comes preconfigured with over 500 different document types organized in process zones and sections based on the TMF reference model.
Web based access
All trial stakeholders can access the eTMF system from their computers browser or device anywhere and at any time.
User Configurable Workflows
Dynamically drive the documents lifecycle with centrally managed tasks, significantly speeding up the creation, review and filing of TMF content.
Central Records Center
All final TMF records are stored in a secure centralized record center allowing review of the eTMF by inspectors and auditors.
Automatically file and batch index documents.
Drag & Drop from Desktop
Using eTMF Connect users can simply drag and drop files into the clinical inbox at the swipe of a mouse and index them later.
Clinical Inbox Emailing
Create study inboxes for clinical sites and external partners to simply email documents directly into the TMF.
Bulk Index Multiple Documents Simultaneously
Reduce the time you spend indexing documents by using the bulk indexing tool, allowing you to specify common metadata before filing documents.
Documents that have been indexed are automatically routed to the correct area of the TMF avoiding misfiling.
Centrally Manage Studies and Sites
You can centrally manage site and investigator information and status without using a CTMS
Study Setup Wizard
Step by step process for setting up a study in the system and managing study design and conduct information
Study Milestone Tracking
Throw out your excel study tracker with our centralized study milestone management
Improved Clinical Oversight
Organize and view documents by study and site to streamline start-up, conduct and close out activities
Strong Core Features & Functionality
Clinical sites can email essential documents directly into the system without a need for a user account
Go back in time to see all previous versions of documents with Integrated Document Versioning
Drag & Drop Functionality
Drag and drop documents directly into the interface or through windows explorer
Business Intelligence & Dashboards
Access and analyse information fast with smart dashboards and strong reporting features
All study stakeholders collaborate through workflows and access content in one central place
Aligned with the TMF Reference Model
Pre-defined configuration is fully aligned with version 3.0. of the TMF Reference Model
Compliant Digital Signatures
Integrated 21 CFR Part 11 digital signatures are embedded into documents to ensure validity and traceability
Iron Tight Compliance
Fully documented and tested in line with 21 CFR Part 11, Annex 11 and GCP
Available on the Cloud
Access your information anywhere any time with fast and reliable deployments on the Microsoft Azure cloud