Electronic Trial Master Files

eTMF

Trial Interactive has been designed by clinical professionals, for clinical professionals to support studies on a global scale. Trial Interactive specializes in the nuances of clinical and eTMF document management, simplifying tasks while keeping the TMF accurate and in regulatory compliance. An extremely flexible and practical solution, Trial Interactive is consistently noted by clinical professionals for providing the most comprehensive yet intuitive features and work flows.

As a secure, cloud-based solution, Trial Interactive enables real-time collaboration for both Sponsors and CROs. Setup your eTMF in a matter of weeks, allowing access to study personnel and partners. Provide study stakeholders an easy to use experience with the benefits of transparency and visibility into your clinical study.

What's New

  • Trial Correspondence:
    Capture email correspondence and automatically render all email content to PDF by simply sending it to the Correspondence Inbox. Messages may be selected for eTMF inclusion in a separate interface. Attachments are checked for duplicates, then added to the eTMF and linked to the original email content.

  • Universal Viewer:
    A new, flexible file viewer renders over 300 formats and simplifies navigation. Load pages instantly and view and compare multiple pages simultaneously, showing text differences, with thumbnails for easy navigation. Run full-text searches on documents and much more with the new universal eTMF viewer.

  • Multi-Factor Authentication:
    Using text messaging or Google Authenticator, Trial Interactive will verify identity with a code in addition to username and password, improving document security.

Are you sick of dealing with unreliable and difficult-to-track paper and hard-format media?

Go Paperless

If you're ready for an eTMF, make sure you choose a 21 CFR Part 11 Compliant eTMF solution

Trial Interactive
is the eTMF choice
of over
3,500
ongoing studies

Why? Because we
make things

EASY

EASY global access, 24/7/365
EASY reporting and audit trails
EASY standardization and centralization of files
EASY risk mitigation
EASY to show significant cost savings over traditional TMF
EASY to manage submission packages
AND  excellent quality management

Want to learn more about
Trial Interactive eTMF?
REQUEST A DEMO

Want to migrate to an eTMF solution but aren't sure where to start?
Ask about our TMF Migration solutions

Always Be Inspection Ready

Drilldown dashlets for real-time overview of eTMF completeness

Placeholders for managing required and expected documents

Real time Report generation capabilities

Comprehensive audit trail

Trial Interactive significantly reduces the costs of corporate IT support, as well as the challenges of tracking all the information with hard copies. It enables you to host your eTMFs online with drag and drop functionality, allowing regulatory administrators to rapidly reorganize content. This accelerates regulatory processes, while providing documentation access to key personnel. With key integrations, Trial Interactive eTMF eliminates the need to use multiple solutions for your clinical needs on a unified technology platform.

Integrated. Innovative. Intuitive.

Integrated with Trial Interactive Suite of Solutions
IRBs, CTMS, & EDC Integrations available
Compliant Digitial & Electronic Signatures
  • Schulman IBR
  • Chesapeake
  • Copernicus
  • Please Review
  • Seclore
  • SimpleCTMS
  • Adobe Sign
  • Docusign

Achieve real-time global regulatory compliance.
Reduce TMF paper and administrative costs/burden.
Eliminate challenges to oversight with Trial Interactive eTMF.

Highlights:

  • A single access point for eTMF documentation
  • Real-time eTMF Completeness view and Milestones
  • Support for essential TMF workflows: document import and coding, quality review, audit and inspection, document certification, and the capture of clinical trial documentation, among others
  • A user-friendly interface supporting major browser
  • A mobile app available for phones and tablets
  • A configurable document management solution for Clinical, Quality, and Regulatory documentation

 

For the Compliance-Focused Enterprise:

  • A fully hosted solution that is 21 CFR Part 11, ERES, GxP and GDPR compliant
  • Alignment with the TMF reference model
  • Additional TMF support with comprehensive TransPerfect Life Sciences TMF Services (Paper and Digital) with flexible staff augmentation
  • Support for global studies with world-wide accessibility and translation services
     

The Trial Interactive platform complies with all current and emerging regulations
including 21 CFR Part 11, ERES, ANNEX 11, GxP, and GDPR.

35%
Reduction in TMF costs

25%
Reduction in Process Time

3/4
Reduction in TMF audit Time

Contact us to learn more about our eTMF solutions

Contact Us