Global Drug Maker Eisai Signs Three-Year Contract Extension for CSC’s Total Regulatory Solution (TRS) As-a-Service
News Release -- March 30, 2016
CSC’s TRS End-to-End Solution Speeds Regulatory Filings
FALLS CHURCH, Va., March 30, 2016--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.”
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.
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.
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.