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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 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
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
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
How do you get access?
3 Steps to Greater Trial Master File Insights
Subscribe to eTMF Connect
Once you’ve evaluated eTMF Navigator and our eTMF Connect solution, it’s time to subscribe. For low monthly fees, charged on a per user basis you can start managing your Trial Master File better today.