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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

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EMC Perspectives: Rethinking Traditional Approaches to Information Governance

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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.


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We at OPEN NETWORKS GMBH stand by our commitment to provide top quality EMC solutions to push your business to the next level. Contact us now to see what we can do for you.