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Electronic Trial Master File (eTMF) Platform Solution

Leveraging advanced technology for efficient study management

Clinical trials produce an enormous amount of documentation that needs to be created, managed, and organized throughout the study lifecycle.

The demands from regulatory agencies and the drug development process at large make it essential that your study documentation is easily accessed, efficiently managed, and thoroughly organized.

At ethica CRO, our eTMF platform is built to:

Facilitate the exchange of clinical trial materials to all stakeholders

Allow for centralized management of clinical trial documentation

Meet the demands of regulatory requirements, audits and inspections

Do you want to learn more about the eTMF technology employed by ethica CRO?

By working with a quality Electronic Trial Master File (eTMF), you can avoid the hassle of paper-based filing and instead organize your data in one centralized location while being able to share the necessary data with all relevant stakeholders.

At ethica CRO, our leveraging of eTMF software minimizes TMF maintenance costs, optimizes document security and accessibility, and guarantees audit readiness.

Our eTMF Technology

We employ eTMF Connect, Montrium’s state-of-the-art platform.

Designed using the TMF Reference Model, eTMF Connect centralizes and standardizes your clinical records enabling both ethica CRO associates and Sponsors to contribute and access clinical documents and information in real-time. We can also configure the platform to allow direct access to inspectors after minimal training.

During the study start-up process, ethica CRO’s highly qualified associates will provide Sponsor and sites with the appropriate level of targeted training so that all stakeholders can benefit from the following key platform features:

Data visualizations & reporting views

Project teams and clinical operations managers can be provided with precise visibility on eTMF completeness, quality, and timeliness.

Flexible roles and permissions

We can create custom roles for the entire clinical team and define their level of access and permission.

Real-Time access to eTMF status

We can provide you with visual views on real-time completeness based on study, country and site milestones

Our eTMF Approach

Our platform combines comprehensive clinical eTMF functionality, advanced collaboration features, and complete scalability to create a dynamic, intuitive and powerful eTMF solution that provides unparalleled benefits and value.

Other eTMF Platform Features

  • TMF Reference Model: Configuration is fully aligned with TMF Reference Model version 3.0.
  • Digital Signatures: Integrated 21 CFR Part 11 digital signatures are embedded into documents to ensure validity and traceability
  • Compliance: Fully documented and tested in line with 21 CFR Part 11, Annex 11 and GCP
  • Clinical Inbox: Clinical sites can email essential documents directly into the system without a need for a user account
  • Centralized Collaboration: All study stakeholders collaborate through workflows and access content in one central place
  • Dashboards: Access and analyze information fast with smart dashboards and strong reporting features
  • 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.
  • Web based access: All trial stakeholders can access the eTMF system from their computers browser or device anywhere and at any time.
  • Central Records Center: All final TMF records are stored in a secure centralized record center allowing review of the eTMF by inspectors and auditors.
  • Granular control over study blinding: eTMF Connect makes controlling blinding from the artifact level all the way to the study level simple and easy, maintaining the blind throughout your studies.