skip to main content

OpenText Documentum for eTMF

Navigate complex clinical trial processes and take complexity and risk out of trial related document management

Documentum for eTMF

What is electronic trial master file (eTMF) software

The ability to effectively plan, collect and maintain essential clinical trial documentation is challenging and, at times, risky. Driven by skyrocketing clinical trial costs, many Life Sciences companies now rely on contract research organizations (CROs) for most clinical trials. While outsourcing to CROs can reduce costs, the additional coordination required to collect and maintain trial documents can increase the complexity of trial document management, exposing both sponsor organizations and the CROs to compliance risk.

OpenText Documentum for eTMF overview

Effectively plan, collect and maintain essential clinical trial documentation with OpenText Documentum for eTMF, part of the OpenText Documentum for Life Sciences solution. Documentum for eTMF allows organizations to control and synchronize study artifacts and track the progress of collecting clinical trial documentation, reducing the complexity and risk for sponsors and CROs, while ensuring fast, secure access to documentation during and after trials.

OpenText Documentum for eTMF features

  • File planning templates

    Reusable templates help streamline and automate file planning and automated workflows ensure that regulatory packages are complete and ready for Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval.

  • Seamless collaboration

    Easily collect and synchronize sponsor, site and CRO trial documentation with workflows and security models designed for enhanced collaboration and productivity.

  • Realtime progress tracking

    Automatically perform quality checks to detect inappropriate documents, unclear images and missing sign-offs to find and complete missing documents. Gain actionable insight into process inefficiencies with interactive dashboard reports.

Benefits of OpenText Documentum for eTMF features

  • Speed trial setup

    Quickly set up trials with reusable templates to ensure consistency for product, trial, country and site-level artifacts.

  • Improve user experience

    Increase productivity and adoption for trial managers and librarians with modular layouts that enable personalized workspaces for viewing information. Easily replace placeholders with completed content with an associated detailed audit trial. Scan paper-based documents using a choice of centralized, distributed and mobile technology.

  • Inspection ready

    Clearly demonstrate compliance with extensive audit trails, access control, lifecycle management and version control of clinical documents and records. Auditor-specific views ensure only what is required can be accessed.

  • Minimize compliance risk

    Eliminate non-compliant workarounds and manual re-work by linking and sharing content for a single, authoritative source for accurate, complete and compliant regulated documentation.

Contact us to speak with a member of the Life Sciences team