eTMF Connect Trial Master File Document Management Software

An Advanced Electronic Trial Master File (eTMF) Solution

 

Take a video tour of eTMF Connect

Montrium’s proven eTMF Connect solution helps life sciences companies better manage their clinical trial documentation. It has been designed using the TMF Reference Model, and centralizes and standardizes your clinical records enabling both sponsors and CRO’s 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/eTMF.

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.

Schedule Live Demo

We understand the 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. We have leveraged our in-depth knowledge of clinical processes and the TMF Reference model to design an eTMF tool which is at the heart of the clinical trial.

Visit Our Blog
Centralizing Clinical Documentation in the Cloud

Perfect For

  • Pharmaceutical Organizations
  • Contract Research Organizations
  • Academic Research Organizations

Built to

  • 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

The eTMF Navigator allows you to 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.

Learn More

Centrally Manage Your Clinical Documents.

Centrally Build and Manage Clinical Documentation in one Place

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 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.

Automatic Filing

Documents that have been indexed are automatically routed to the correct area of the TMF avoiding misfiling.

Send me pricing
Automatically Batch Index Clinical Documents with eTMF Connect

Centrally Manage Studies and Sites

Clinical Directory

Allows you to 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

Add Sites & Studies through a Clinical Directory Wizard
See Deployment Options

Study Milestone Tracking

Throw out your excel study tracker with our centralized study milestone management