ISI and Cadence Pharmaceuticals Collaborate to Leverage Software-as-a-Service Technology
SaaS Model Delivers ISI's Flagship Product, eCTDXPress, Meeting Need for Swift Implementation
WHIPPANY, N.J., Mar 22, 2010 (BUSINESS WIRE) -- Cadence Pharmaceuticals, Inc., is now positioned to send regulatory submissions through the U.S. Food and Drug Administration's Electronic Submissions Gateway (ESG) by using eCTDXPress, ISI's market-leading software product for managing and reviewing electronic submissions. Cadence is a biopharmaceutical company focused on in-licensing as well as on developing and commercializing proprietary product candidates principally for use in hospital settings. Cadence submitted its first New Drug Application in May 2009 for its investigational product candidate, intravenous acetaminophen.
Cadence and ISI partnered to determine the best delivery model for eCTDXPress and elected to use a software-as-a-service (SaaS)--enabled solution because of its short implementation time, secure framework, and ability to create submissions for regulators all over the world. SaaS is a deployment model whereby the software provider hosts the application and delivers it to the client as needed and on demand.
"Our collaboration with ISI enables Cadence to generate electronic submissions leveraging our internal expertise, while technical infrastructure and integrity are fully supported by ISI," said Emily Onkka, director of regulatory operations and submissions at Cadence. As part of the project, ISI performed the initial deployment and is providing ongoing information technology infrastructure and technical support, as needed, for submission activities through the Electronic Submissions Gateway, including sponsorship of the electronic signature certificate.
"We enjoyed collaborating with Cadence because they share our vision for a better, more efficient drug application submission process," said Rolando Sa, director of software services at ISI. "One appeal of this delivery model is that it is available to pharma and biotech companies of all sizes--accommodating a wide range of requirements--that need to quickly and effectively deploy the software."
Across the continuum of functions and business units at pharmaceutical companies, SaaS-enabled technologies have gained popularity because they can be deployed quickly, they don't require significant up-front capital investment, and they eliminate both the need for servers and associated maintenance costs. Gartner predicts the SaaS Delivery within the Enterprise Application Software markets will show consistent growth through 2013, with worldwide SaaS revenue totaling an estimated $14.4 billion based on total software revenue. According to Gartner, 2008 revenue was $6.4 billion.(1)
Skeptics have been reluctant to adopt the technology, in part because of security concerns. Using VMware's virtualization system, ISI's SaaS model provides life sciences organizations with a distinct and self-contained environment in order to maintain data protection. Data is also preserved through daily incremental backup and weekly full backup. Other benefits include the ability to scale up or down as needed; round-the-clock accessibility to ISI's technical team; complete control over submission timelines and system upgrades; capability to make an electronic submission; and instant access to files.
Tags: regulatory submission; electronic submission; electronic submission gateway; software as a service, SaaS, Gartner, Rolando Sa, Cadence Pharmaceuticals, ISI, Image Solutions Inc, New Drug Application, eCTDXPress, FDA
Suggested Links: FDA eCTD Guidance
About Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing as well as on developing and commercializing proprietary product candidates principally for use in hospital settings. For more information about Cadence, visit www.cadencepharm.com.
About Image Solutions, Inc.
Founded in 1992, Image Solutions, Inc. (ISI), is a proven market leader in providing submission solutions, process services, and consulting for life sciences companies as ways of improving the clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and has since delivered thousands of electronic and electronic Common Technical Document submissions. ISI serves the world's top 50 pharmaceutical and biotech organizations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey, and operations throughout the United States, Europe, and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to more than 20 recognized charitable organizations. For more information, visit the company Web site at www.imagesolutions.com.
(1) ("Market Trends: Software as a Service, Worldwide, 2008-2013, Update"; Sharon A. Mertz, Chad Eschinger, Tom Eid, Hai Hong Swinehart, Chris Pang, Ben Pring; November 4, 2009)
SOURCE: Image Solutions, Inc.