Global Drug Maker Eisai Signs Three-Year Contract Extension For CSC’s Total Regulatory Solution (TRS) as-a-Service
March 30 2016 - 10:00AM
Business Wire
CSC’s TRS End-to-End Solution Speeds Regulatory
Filings
CSC (NYSE: CSC), a global leader in next-generation IT services
and solutions, announced today that Eisai Inc. has signed a
three-year contract extension for CSC's Total Regulatory Solutions
(TRS) as-a-Service. The agreement extends the ongoing life sciences
software and cloud-hosting services CSC provides to Tokyo-based
Eisai Co., Ltd.’s U.S. pharmaceutical subsidiary until December
2019.
The services-expansion contract is the latest example of CSC’s
innovative digital transformation solution platforms across the
life sciences value chain which is designed to help pharmaceutical,
medical technology, diagnostics and consumer healthcare companies
ensure regulatory compliance, engage with customers, and accelerate
business growth by integrating new technologies into a digital
ecosystem. It also underscores CSC’s commitment to the fast-growing
and rapidly evolving life sciences IT market segment.
CSC has been providing regulatory information management (RIM)
solutions and business process services to help bring exceptional
value, service and speed to Eisai’s regulatory submission process
since 2012. RIM is the process that helps facilitate a
pharmaceutical company’s management and submission of the
information required by regulatory agencies in different countries
to obtain approvals to market drugs.
As a long-standing CSC software and services client in the life
sciences segment, Eisai uses the full stack of CSC’s TRS software
products hosted on CSC CloudCompute to support document management,
publishing and regulatory submissions to the U.S. Food and Drug
Administration and other global regulatory agencies.
“Combining CSC’s TRS solution and Eisai’s global regulatory
processes enabled several submissions to occur in multiple markets
simultaneously,” said Martina Struck, president, Global Regulatory
Affairs at Eisai Inc.
"CSC's solution aligns to our IT strategy of moving aggressively
to the cloud," said Dan Utzinger, vice president, Eisai Strategic
Information Systems, Americas IT director.
“Digital RIM is taking on increasing strategic importance in
organizations as it evolves to drive improved efficiency and
productivity,” said John Bell, CSC industry general manager for
life sciences. “As large pharma companies look to modernize and
consolidate disparate regulatory stacks to achieve a single,
accurate view across both the enterprise and the development life
cycle, solutions like CSC’s TRS endeavor to save time, reduce
errors, and accelerate innovation and business growth.”
About TRS
CSC’s TRS – an end-to-end solution around regulatory compliance
in the Cloud – dramatically accelerates a company’s ability to file
regulatory submissions with regulatory agencies around the world.
Complying with globally stringent regulations in the
biopharmaceutical product development process requires a
comprehensive solution of software and services. CSC’s TRS provides
templates and standardized workflows that help authors in
functional areas across complex organizations and along the product
development life-cycle maintain visibility and control over
critical information according to required regulatory
guidelines.
About CSC
CSC (NYSE: CSC) leads clients on their digital
transformation journeys. The company provides innovative,
next-generation technology services and solutions that leverage
deep industry expertise, global scale, technology independence and
an extensive partner community. CSC serves leading commercial and
international public sector organizations throughout the world. CSC
is a Fortune 500 company and ranked among the best corporate
citizens. For more information, visit us at www.csc.com.
About Eisai
At Eisai Inc., human health care is our goal. We give our first
thoughts to patients and their families, and helping to increase
the benefits health care provides. As the U.S. pharmaceutical
subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate
commitment to patient care that is the driving force behind our
efforts to help address unmet medical needs. We are a fully
integrated pharmaceutical business with discovery, clinical,
manufacturing and marketing capabilities. Our key areas of
commercial focus include oncology and specialty care (Alzheimer's
disease, epilepsy and metabolic disorders). To learn more about
Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product
creation organization that includes R&D facilities in
Massachusetts, New Jersey and Pennsylvania, as well as a global
demand chain organization that includes facilities in Maryland and
North Carolina. Eisai's global areas of R&D focus include
neuroscience; oncology; metabolic disorders; vascular, inflammatory
and immunological reaction; and antibody-based programs.
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CSC ContactsCSCRichard AdamonisGlobal Media
Relations862.228.3481radamonis@csc.comorCSCNeil DeSilvaInvestor
Relations703.641.3000neildesilva@csc.comorEisai ContactEisai
Inc.Patricia Councill201.746.2139Patricia_Councill@eisai.com
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