eTMF Software

eTMF Software Systems

Managing an electronic trial master file (eTMF) is a complex and labor-intensive effort. Centralize and streamline your clinical activities with MasterControl eTMF software systems.

Administering a clinical study’s TMF goes far beyond just managing the creation, review and approval of TMF content. Every study has its own information requirements and complexities. Handling all contributor and participant interactions gets overwhelming quickly. MasterControl eases these burdens. With the eTMF Manager™ solution, you gain real-time visibility into the status of all clinical activities. Based on the TMF Reference Model, the solution simplifies the management of all the documents, tasks, milestones and activities that are required during a clinical trial.

MasterControl eTMF Manager™

A best-practice approach to total TMF management. All on a single platform.


Industry Standard Configuration


The eTMF Manager is based on the Drug Information Association (DIA) TMF Reference Model. Combining the industry best-practice configuration with our process management excellence enhances real-time visibility into all TMF activities. The solution helps you plan, assign, create, review and approve all TMF artifacts with more efficiency. Download the free TMF checklist to see how it’s structured.


Simplified GCP Compliance


Every clinical study is complex in different ways. Documentation, collaboration and milestone requirements always vary. But all these TMF elements must be managed effectively as proof of a study’s compliance with current good clinical practice (GCP). MasterControl securely maintains all required information and interactions — and they’re always kept in a complete, compliant and audit-ready state.


Streamlined Information Transfer


MasterControl’s eTMF software has built-in bulk import/export functionality. The system’s multiple exchange methods smooth interactions with partners like contract research organizations (CROs) and sponsors. They also make it easier for teams to collaborate. Plus, they simplify the transfer of study documentation at study closeout.


Optimized Virtual Collaboration


The system serves as a shared digital collaboration space where contributors can work on TMF documents. Authorized internal and external contributors (e.g., sponsors, CROs and study sites) can share and exchange TMF content in the secure collaboration environment.

Trusted By


Completely Digitized TMF Management

It’s inherently problematic to manage tons of TMF documentation with a paper-based system. That’s why leaders turn to proven software systems to manage TMF processes. Digitization provides a superior, efficient approach to TMF management. Our proven eTMF solution increases visibility into clinical trials. It also digitally integrates TMF activities with other compliance-critical functions.


User-Friendly Automated Tool

MasterControl eTMF Manager provides a “project plan” view of TMF artifacts and processes. Visibility into the status of all TMF-related activities is continually maintained. The system also sends automated notifications of milestones and task assignments. This helps keep all designated personnel, including those external to the organization, up to speed with their respective activities.

Take the headaches out of eTMF management.

There’s an easier way to organize and track your TMF artifacts and activities.

Get Your Free Data Sheet