eTMF Navigator 2017-04-17T15:59:06+00:00

This Changes. Everything.

eTMF Navigator

for eTMF Connect

You’ve never managed TMF content this way before…




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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.

Navigate Your Entire Trial Master File

Navigate Your Entire TMF

in One Interface

Users can navigate across hundreds of thousands of TMF artifacts from a single centralized location, enabling them to quickly identify all available, expected or missing artifacts. You can navigate at the study, country, site and investigator level or by process zone and section making it easy to see subsets of artifacts quickly and intuitively.

  • Modify Artifact Metadata Interactively
  • Navigate Your Study Structure Intuitively
  • Find TMF Artifacts Through Dynamic Filtering and Search

Manage eTMF Completeness

in Real-Time

Leveraging the TMF Reference Model, document placeholders for expected and missing documents are created automatically in the relevant process zones and sections. Each artifact is linked to study, country or site milestones allowing the system to indicate which artifacts are expected and which artifacts are truly missing.

  • Be in Control of eTMF Completeness at All Times
  • View eTMF Completeness Across all Study Levels
  • Keep Completeness in Sync with Study Milestones
eTMF Competeness Reporting
Identify Missing Artifacts in Minutes

Identify Missing Artifacts

in Minutes, not Months

Using visual color coding and comprehensive filtering it is easy to detect missing artifacts at different levels very quickly. Documents can be uploaded to a specific artifact placeholder directly in the Navigator making it easy to fill gaps.

  • Filter by Country, Site and Artifact to Identify Missing Documents
  • Improve TMF Completeness by Uploading Documents to Pre-Defined Placeholders
  • Use Visual Cues to Identify Artifact Status

Facilitate eTMF Audits & Inspections

with Confidence

TMF completeness indicators coupled with an inspector specific view allows to you better prepare for audits and inspections and allow auditors and inspectors direct access to final artifacts in the TMF. They are able to use the advance filtering to easily trace through study events and information.

  • Audit Ready TMF at all Times
  • Inspector/Auditor View Gives Direct Access to Final Artifacts
  • Filtering Provides Inspectors with Path to Study Events & Information
Inspector View on eTMF
Managing Clinical Sites and Countries

Manage Country and Site Progress

As It Happens

Whether you have a CTMS or not, you can manage all of the countries, sites and investigators that are participating in your trial directly in the Navigator. There are predefined milestones at each level which allows you to track trial progress and identify the artifacts required at each phase.

  • Build Out Your Study Directly in the Navigator
  • Manage & Track Study Milestones Automatically
  • Change the Status of Countries and Sites with Ease