eTMF Connect Trial Master File Document Management Software

An Advanced Electronic Trial Master File (eTMF) Solution

 

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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.

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.

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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.

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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

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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.

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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.

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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
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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

Manage Clinical and Regulatory Content in One Place

Eliminate Duplicate Records when you connect eTMF Connect and RegDocs Connect

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Strong Core Features & Functionality

Clinical Inbox for External Clinical Documents

Clinical Inbox

Clinical sites can email essential documents directly into the system without a need for a user account

Keep Track of Versions of eTMF Documents

Document Versioning

Integrated document versioning allows you to go back in time to see all previous versions of documents

Drag and Drop Clinical Documentation into your TMF

Drag & Drop Functionality

Drag and drop documents directly into the interface or through windows explorer

Dashboards and Reports show health and status of your trial master file

Business Intelligence & Dashboards

Smart dashboards and strong reporting features allow you to access and analyse information fast

Centrally collaborate on clinical documentation

Centralized Collaboration

All study stakeholders collaborate through workflows and access content in one central place

Aligned with the TMF Reference Model

Aligned with the TMF Reference Model

Pre-defined configuration is fully aligned with version 3.0. of the TMF Reference Model

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Compliant Digital Signatures

Integrated 21 CFR Part 11 digital signatures are embedded into documents to ensure validity and traceability

Compliance with 21 CFR Part 11 and Annex 11

Iron Tight Compliance

Fully documented and tested in line with 21 CFR Part 11,  Annex 11 and GCP

Host your eTMF in the Cloud

Available on the Cloud

Fast and reliable deployments on the Microsoft Azure cloud means you can access your information anywhere any time

Ready to get started?

See how eTMF Connect could help your organization better manage clinical trial documentation

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