Electric Trial Master File
EMC Documentum Electronic Trial Master File (eTMF) solution enables life sciences organizations to easily and effectively control and synchronize study artifacts, track progress in clinical trial documentation, and ensure fast, secure access to documentation both during and after the trial.
Solution Overview: EMC Documentum Electronic Trial Master File Download Now
EMC Perspectives: Rethinking Traditional Approaches to Information Governance Download Now
ACCELERATED TRIAL SETUP Our Electronic Trial Master File (eTMF) solution enables you to quickly set up trials with reusable templates to ensure consistency for product, trial, country, and site-level artifacts. Streamline processes with auto-filing and auto-naming rules using file planning and workflows to ensure documentation completeness.
COMPLETE COMPLIANCE Enable good clinical practices (GCP) and 21 CFR Part 11 requirements including electronic signatures, dynamic user access controls, print controls, and preconfigured, dynamic watermarking and overlays.
CONFIDENT COMPLIANCE Quickly respond to regulatory audits and inspections with rich search features, real-time reporting, and inspector workspace and security and enable easy setup for audits and immediate location of electronic documents during regulatory reviews. With Investigator Portal, investigators can directly view, upload, and act on documents.
LOWER COSTS WITH CLOUD DEPLOYMENT Reduce the cost and administrative burden of on premise deployments. With EMC, you gain choice and flexibility in deployment models―private, public, and managed services.