EMC Documentum Electronic Trial Master File Solution
- Pharmaceutical Companies
- Contract Research Organizations
- Clinical Operations
- Reduce the risk of trial delays with documentation completeness
- Accurately track the progress of clinical trial documentation
- Quickly comply with regulatory requirements, audits, and inspections
ACCELERATED TRIAL SETUP
LOWER COSTS WITH OnDEMAND
The ability to effectively plan, collect and maintain essential clinical trial documentation is challenging and at times, risky. Driven by skyrocketing clinical trial costs, most life sciences companies now rely on contract research organizations (CROs) for the majority of clinical trials. While outsourcing to CROs can reduce costs, these partnerships increase the complexity of trial document management. The additional coordination required to collect and maintain trial documents can expose both the sponsor and the CRO to compliance risk.
EMC Documentum Electronic Trial Master File (eTMF), part of the EMC Documentum for Life Sciences solution suite, 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. The solution ensures reliable regulatory compliance by enabling compliance with Good Clinical Practices (GCP), 21 CFR Part 11 including electronic signatures capabilities and other compliance capabilities such as dynamic user access controls, print controls, and preconfigured, dynamic watermarking and overlays.
Efficiently and securely operate the extended enterprise across geographies and external organizations with workflows, security models and collaboration capabilities designed for enhanced productivity and the virtualization of the clinical trial process.
The foundation of the solution includes the Documentum® Enterprise Content Management platform, Documentum® D2 for configuration and intuitive user interfaces, implementation and migration services.
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Gain control of documentation, automate workflows across the enterprise and ensure GMP compliance with EMC Documentum Quality and Manufacturing
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Deploy content management solutions powered by private cloud technology to achieve greater agility, lower risk, and predictable cost management.
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Use EMC Captiva products to automate document capture and enterprise capture and to transform information for content management systems.
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Simplify your document lifecycle management and enhance your user experience.
EMC Documentum Information Rights Management
Manage sensitive information wherever it resides to ensure document security.
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Automate content-intensive business processes to increase operational efficiency, make better decisions, and reduce risk.
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Put information to work in your business, solve problems, improve performance, drive innovation, and shape decisions.
EMC Industry Consulting
Realize your ambitions in an information economy through the worldwide capabilities and deep industry understanding of EMC Consulting.
- 15-Minute Guide to Efficient and Compliant Management of GMP Controlled Documents
- A 15-Minute Guide to Clinical Trial Document Management and the eTMF
- 15-Minute Guide to Protecting and Controlling Content Wherever it Resides
- EMC Consulting Regulated Information Management for Life Sciences
- Assuring Life Sciences Compliance in the Private Cloud
News & Blogs
May 07, 2013EMC Expands Portfolio of Documentum Solutions for Industries
Jan 08, 2013EMC Helps Leading Vaccine Manufacturer Boost IT Efficiency; Reduces TCO 20% with Life Sciences Solution
May 22, 2012EMC Delivers Information Management Software and Solutions to Accelerate Customers’ Journey to the Cloud and Transform Business Processes
May 22, 2012EMC Delivers Documentum Solution Suite for Life Sciences
Learning & Events
OCT 8-9, 2013Drug Information Association (DIA) Europe Clinical Forum 2013The Convention Centre, Dublin, Ireland
OCT 10, 2013Life Sciences Momentum Users Group8:00 AM – 4:00 PM EST
Lincoln Financial Field, Philadelphia, PA
February 25-26, 2014GLOBAL eCTD MANAGEMENT CONFERENCEMillennium Gloucester Hotel, Kensington, London, U.K.
March 11-13, 2014CLINTECH 2014Hyatt Regency Cambridge, Cambridge, MA
June 15-19, 2014DIA 2014San Diego Convention Center, San Diego, CA