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 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.
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.
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
- Documentum for eTMF product overview
- Digital technologies for clinical trials: Toward faster time to market white paper