eTMF Software Systems

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.

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.

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.

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.