A NEXT-GENERATION ELECTRONIC TRIAL MASTER FILE OFFERING FROM EMC CONSULTING

A NEXT-GENERATION ELECTRONIC TRIAL
MASTER FILE OFFERING FROM EMC CONSULTING
Improving clinical trial compliance and efficiency with
collaboration and content management
ESSENTIALS
• Life Sciences clinical trial management is
paper-based, manual, and risky
• EMC Consulting builds electronic trial
master file solutions based on EMC and
Microsoft technology
• Better agility—Trials set up 50 percent
faster at a lower TCO
BUSINESS CHALLENGES
Life Sciences companies that engage in clinical trials are required to document the pertinent
aspects of the trial. The trial documents enable the conduct of a clinical trial, and prove the
quality of the data produced. The FDA requires that trial documents are filed and maintained
in both the trial sponsor and the investigator/institution files. By federal mandate, the final
close-out of a trial can only be done when the clinical site monitor has reviewed and confirmed
that all necessary documents are in the appropriate files.
Because of these stringent reporting requirements, sponsors are often cited in internal and
regulatory audits for discrepancies in the trial master file (TMF). Many times required documents
are missing at either the sponsor or trial site. Missing documents are not the only issue; version
discrepancies are as dangerous as missing documents from an audit perspective. Inaccuracies
abound because processes for capturing essential documents are often labor-intensive and
slow. In fact, most workers spend 75 percent of their time recreating content that already exists.
Process inefficiency causes companies to store two to three physical copies of their TMF
records. In addition to the standard copies, all regulated content is often stored in 10 places.
This means that manual methods for obtaining review and approval of TMF documents adds
time to study startup and, therefore, to the entire trial timeline. Life sciences organizations
need to develop consistent electronic trial master file (eTMF) processes and archiving to
reduce R&D cost and ensure regulatory compliance.
SERVICE DESCRIPTION
EMC Consulting provides a next-generation eTMF solution that goes beyond paper folders and
covers the entire content lifecycle. Our eTMF solution streamlines eTMF content ingestion, control,
storage, syndication, and archiving based on leading industry requirements and processes.
EMC Consulting enables pre-defined scanning according to common data model that enables
rapid and automated trial set-up. We provide best-practice based eTMF content management
and control including a fully-integrated investigator and site monitor portal leveraging Microsoft
SharePoint® and EMC® products. This best-in-class, accelerated delivery model enables ease
of use, integration with email, management of eTMF content via standard taxonomies (e.g.,
ICH guidelines), integration with regulatory submissions applications, archiving, and searching.
EMC Consulting provides consistent methods for electronically managing document content
between investigator sites and the sponsor. We deliver efficient mechanisms for the review
and approval of documents captured in the eTMF repository, and leverage leading industry
practices for document workflow. We also provide the ability to scale expansion of eTMF
management by leveraging the power of the EMC Documentum® D6 platform and standard
EMC framework called the enterprise core solution.
SERVICE OVERVIEW
EMC Consulting’s industry experts provide
the following eTMF consulting services and
accelerators (e.g., starter deliverables) to help
you quickly reach your defined target state.
• Strategy & Planning—Mobilize the initiative,
clarify objectives, and develop your roadmap
for the future state of eTMF
• Process Excellence—Update business
processes to reduce activities that do not add
value, and follow industry leading practices
• Requirements & Design—Define solution
requirements based on leading industry
practices, and develop a solution architecture
and design for the eTMF solution
• Solution Implementation—Program management, configuration/development of EMC’s
starter framework or other solution based on
business needs, validation, deployment,
change management, and training services to
implement an eTMF solution
• Ongoing Support—Services for application
support, hosting, and business process
outsourcing
SERVICE VALUE
EMC Consulting has recognized expertise in integrating compliance, business processes, and
technology into innovative and practical IT solutions. The EMC Consulting eTMF solution is a
case-based application which enables trials to be set up 50 percent faster, at a substantially
lower cost. It also reduces time spent during the trials managing TMF documents, while
improving compliance and audit readiness. Because our solution leverages configuration
versus custom coding, it requires less resources, is less complex, and minimizes deployment
risks. The solution also requires less validation effort which improves application agility by
enabling the sponsor to initiate more trials faster at a lower TCO.
EMC Consulting combines knowledge of clinical business processes, business/technology
roadmap development, implementation, validation, and program management to deliver a
cost effective eTMF solution. The EMC Consulting eTMF solution enables you to:
•Reduce R&D costs
•Increase efficiency and scalability
•Reduce risk and improve compliance
EMC CONSULTING
CONTACT US
To learn more about EMC Consulting
services, contact your local representative
or authorized reseller—or visit us at:
www.EMC.com/consulting.
As part of EMC Corporation, the world’s leading developer and provider of information infrastructure technology and solutions, EMC Consulting provides strategic guidance and technology
expertise to help organizations exploit information to its maximum potential. With worldwide
expertise across organizations’ business, applications, and infrastructure, as well as deep
industry understanding, EMC Consulting guides and delivers revolutionary thinking to help
clients realize their ambitions in an information economy. EMC Consulting drives execution
for its clients, including more than half of the Global Fortune 500 companies, to transform
information into actionable strategies and tangible business results.
EMC2, EMC, Documentum, the EMC logo, and where information lives are registered trademarks or trademarks of EMC Corporation in
the United States and other countries. All other trademarks used herein are the property of their respective owners. © Copyright 2011
EMC Corporation. All rights reserved. Published in the USA. 1/11 Service Overview H8546
EMC Corporation
Hopkinton, Massachusetts 01748-9103
1-508-435-1000 In North America 1-866-464-7381
www.EMC.com