CSC’s TRS includes software and services that address every aspect of the regulatory operations process
Uniquely holistic, integrated, end-to-end product and services suite addresses the increasing demands of regulatory submissions management, transforming efficiency and speed to market for life sciences organisations.
CSC Life Sciences has unveiled its vision and solution portfolio for complete, end-to-end regulatory submissions management. CSC’s Total Regulatory Solution (TRS) is unique in the industry, being the only proposition to offer cradle-to-grave business process automation and management across the entire regulatory operations process.
In December 2010, CSC boosted its respected regulatory content management solution and services portfolio with the strategic acquisition of ISI, the leading provider of electronic publishing solutions to the life sciences industry. CSC TRS is the resulting, end-to-end software and regulatory services proposition, providing complete control and visibility across the creation, review, approval, consumption and exchange of regulated content as well as of other, associated mission-critical documents.
The acquisition also brought together two highly regarded managed-services businesses, giving life sciences organisations access to comprehensive support across their regulatory operations activities from a single global service provider.
“Today the regulatory landscape is more challenging than ever, as authorities implement new initiatives designed to ensure product quality and patient safety. Requirements include greater transparency and traceability, as well as the adoption of consistent processes for managing regulatory submissions, which must now be published electronically,” said Marty Magazzolo, Global Practice Director, Life Sciences Software Solutions Group at CSC.
“At the same time, a persistently difficult financial climate requires that life sciences organisations must look to penetrate new markets quickly and efficiently,” he said. “In practice, this means being able to navigate the varying regulatory requirements of each new market, which puts additional pressure on R&D operations that are already overstretched. Profitability and speed to market demand efficient, effective and compliant processes.”
CSC’s value proposition with TRS is to alleviate that burden through a complete Regulatory Information Management solution suite underpinned by a full complement of professional services ranging from consultancy and managed information technology services — including software-as-a-service application hosting via CSC’s industry-leading cloud infrastructure — to partial or full business process outsourcing.
CSC’s TRS includes software and services that address every aspect of the regulatory operations process. Each product in the suite is tightly integrated, resulting in high-quality, intelligent documents, dossiers and registration records that increase R&D productivity.
Capabilities span the planning and assembly of submissions, document creation and approval, publishing, viewing and navigation, archiving, and submissions tracking and lifecycle management, and they facilitate the coordinated management of all paper and electronic submissions, including both electronic Common Technical Document (eCTD) and non-eCTD-electronic-submission formats. Once content is stored electronically, it can be accessed quickly and repurposed repeatedly, thereby reducing associated administrative overhead and expediting companies’ speed to market.
The software applications making up the CSC TRS product set can be purchased as a series of standalone modules or as a complete end-to-end solution. Alternatively, the functionality can be delivered via a software-as-a-service delivery model.
A comprehensive range of sophisticated and flexible business process outsourcing services, meanwhile, offer companies the option to offload some or all of their regulatory operations activities so that they can focus on core business activities. These include offshore services, which can help bring down the costs of managing routine administrative tasks.
Marty concludes: “The rich heritage and experience of CSC in life sciences content management combined with our regulatory process management expertise add up to something much greater than the sum of the parts. In TRS, CSC has the most complete offering available anywhere today, adding unique value and alleviating substantial pressure for the industry at a particularly challenging time in its evolution.”
CSC is a global leader in providing technology-enabled business solutions and services. Headquartered in Falls Church, Virginia, CSC has approximately 93,000 employees and reported revenue of $16.2 billion for the 12 months ended July 1 2011. For more information visit the company's website on www.csc.com
Carina Birt, Sarum PR
PR for CSC Life Sciences
+44 1722 411150
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