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 Cloud Deployment
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.
The EMC Documentum Electronic Trial Master File (eTMF) solution, 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 signature capabilities, 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 EMC Documentum enterprise content management platform, EMC Documentum D2 for configuration and intuitive user interfaces, and implementation and migration services.
EMC Captiva - Intelligent Enterprise Capture
Convert paper, faxes, and other content into application-ready information.
EMC Document Sciences xPression Enterprise Edition
Automate the creation and multi-channel delivery of timely, accurate, and personally relevant customer communications across the enterprise.
EMC Documentum D2
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.
Documentum xCelerated Composition Platform – xCP
Automate content-intensive business processes to increase operational efficiency, make better decisions, and reduce risk.
Capitalize on the benefits of the cloud and leverage the strengths of EMC and VMware in cloud virtualization, security, storage, and information management.
EMC Enterprise Information Management
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.
EMC Documentum Quality and Manufacturing Solution
Gain control of documentation, automate workflows across the enterprise, and ensure good manufacturing practices (GMP) compliance.
EMC Enterprise Archiving Solution
Control structured and unstructured information growth while significantly reducing costs with live archiving and application retirement solutions.
Dell EMC Perspectives
- 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
- Assuring Life Sciences Compliance in the Private Cloud
- EMC Consulting Regulated Information Management for Life Sciences
Training & Events
May 4-7, 2015EMC WorldThe Venetian, Las Vegas, NV