EMC Documentum Electronic Trial Master File Solution Overview


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This solution overview describes the EMC Documentum for Life Sciences eTMF Solution which provides a single source, enterprise-class solution that ensures clinical trial teams can easily and effectively track progress in trial documentation, control and synchronize study artifacts, and ensure fast, secure access both during and after the trial.

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EMC Documentum Electronic Trial Master File Solution Overview

  1. 1. EMC® DOCUMENTUM® ELECTRONIC TRIAL MASTER FILE SOLUTION Ensuring documentation completeness and compliance for clinical trials ESSENTIALS Faster trial setup and approval with an eTMF solution that's Chances are, you're trying to control the skyrocketing costs of clinical trials by relying secure, compliant and readily • HOW MUCH DOES A MISSED DAY TO MARKET COST YOUR BUSINESS? on contract research organizations (CROs) for the vast majority of your trials. But accessible across multiple • adding more resources—especially third parties—also adds enormous complexity to trial sites document management. The additional coordination required to collect and maintain Improved productivity and vast numbers of trial documents from these partners can expose both you and the CRO efficiency thanks to an to compliance risk. And the resulting delays in bringing a product to market are intuitive, easy-to use user prohibitively expensive. interface Seamless collaboration with CROs, inspectors and other • With the EMC Documentum Electronic Trial Master File (Documentum eTMF) solution, you can reduce this complexity and risk. Part of the EMC Documentum for Life Sciences solution suite, Documentum eTMF helps you centrally control and synchronize study third parties for document • artifacts, track progress in clinical trial documentation, and ensure fast, secure access collection and synchronization to documentation both during and after trials. You'll realize gains in efficiency, Real-time progress tracking of clinical trial documentation consistently manage clinical trial documents according to Good Clinical Practices and ensure inspection-readiness. Continual preparedness for TAKE THE COMPLEXITY AND RISK OUT OF CLINICAL TRIAL inspections and audits • DOCUMENT MANAGEMENT Accuracy and consistency Documentum eTMF is a purpose-built solution that leverages EMC Documentum, the through full support for • industry's leading and most scalable content management platform. EMC Documentum electronic standards • for Life Sciences solutions harness an information architecture based on the industry- Scalability for growth and standard Drug Information Association (DIA) Electronic Document Management (EDM) global operations with a proven, trusted, cloud-ready platform and Electronic Trial Master File (eTMF) reference models for consistent document modeling. Documentum eTMF takes advantage of this robust platform to address the challenges of planning, creating, collecting, tracking and maintaining massive volumes of trial documentation on a global basis. FAST, ACCURATE TRIAL PLANNING, SETUP AND APPROVAL Leveraging the dictionaries, taxonomies and object models of these reference models, Documentum eTMF facilitates the management of accurate, consistent and complete documentation. Streamlined, automated file planning at the product, trial, country and site level, combined with automated workflows, helps you manage regulatory packages that are sent for Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval. An electronic document repository provides centralized control over documentation and allows remote sites to easily access and share information. Authorized users can also access and navigate documents such as consent forms, indemnity contracts and investigator CVs on demand.
  2. 2. GAIN FLEXIBILITY WITH A CLOUDREADY OR ON-PREMISE SOLUTION EMC gives you choice and flexibility when deploying Documentum eTMF to align with your security, budget and IT administration requirements. SEAMLESS COLLABORATION Documentum eTMF makes it easy to collect and provide access to trial documentation from CROs and sites. By integrating compliance and security models and enabling controlled access, it facilitates safe information sharing across the extended enterprise and ensures that people see only what's relevant to them. This seamless collaboration reduces cycle time when monitoring clinical studies, assembling submissions and managing changes to procedural documents. REAL-TIME TRACKING OF DOCUMENTATION Because Documentum eTMF helps users efficiently find and access content (without having to navigate multiple systems), your organization can monitor clinical studies and For example, with EMC OnDemand, manage trial progress in less time. The solution gives you: you can reduce total cost of • Full transparency and access to clinical documentation at all stages of a trial • Multi-stage, automated and real-time progress tracking • Study-monitoring with the ability to flag missing documents and missed deadlines ownership by 30%-60% and minimize demands on IT staff. Alternatively, you can choose a traditional on-premise deployment that gives you full control. Regardless of your choice, EMC offers enterprise-grade, best-in- IMPROVED PRODUCTIVITY With an intuitive, simple user interface, Documentum eTMF is easier than ever for people to learn and use. Modular layouts enable them to personalize their workspaces and class security, backup and recovery optimize them for viewing information. The solution also offers: options from VMware, RSA and EMC • Specific user interfaces for trial managers, librarians, site monitors and others • Easy ways to replace document placeholders with completed content and capture so you can deploy Documentum eTMF with confidence. associated, detailed audit trails • Centralized and distributed branch-office scanning of paper-based documents via EMC Captiva to centrally manage all documents as digital resources PERSISTENT INSPECTION-READINESS Leveraging the features of Documentum eTMF, you can maintain a continual state of preparedness for inspections. Inspectors have a dedicated interface that allows them to see the TMF categorized by study, site or date. And using faceted navigation based on industry-standard reference model dictionaries and taxonomies, your team can quickly retrieve requested documents. The result? Quicker response to audits, streamlined inspections and faster approvals. UNCOMPROMISED REGULATORY COMPLIANCE With Documentum eTMF, you can clearly demonstrate 21 CFR Part 11 compliance through extensive audit trails, access controls (including e-approval and e-signature support), distribution and version control, and lifecycle management. The solution also supports print-control services and preconfigured, dynamic watermarking and overlays to ensure document security. CONTACT US GET STARTED TODAY To learn more about how EMC It's time to take the complexity out of planning and maintaining your clinical trial products, services, and solutions can help solve your business and IT challenges, contact your local representative or authorized reseller—or visit us at www.EMC.com. documentation. Documentum eTMF helps you boost efficiency, centrally manage trial documents and ensure inspection-readiness. To learn more, visit us at www.emc.com. EMC2, EMC, the EMC logo, and Documentum, are registered trademarks or trademarks of EMC Corporation in the United States and other countries. © Copyright 2013 EMC Corporation. All rights reserved. Published in the USA. 12/13 Solution Overview H11131.2 EMC believes the information in this document is accurate as of its publication date. The information is subject to change without notice.