Cadence Pharmaceuticals, a biopharmaceutical company focused on in-licensing, development and commercialization of proprietary product candidates, has said that it is ready to send regulatory submissions through the US FDA’s Electronic Submissions Gateway (ESG) by using eCTDXPress, ISI’s software product for managing and reviewing electronic submissions.
Cadence submitted its first new drug application in May 2009 for intravenous acetaminophen, its investigational product candidate. It has partnered with ISI to identify the best delivery model for eCTDXPress and has chosen 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 worldwide.
Pursuant to the project, ISI performed the initial deployment and is providing ongoing information technology infrastructure and technical support, as needed, for submission activities through the ESG, including sponsorship of the electronic signature certificate.
Emily Onkka, director of regulatory operations and submissions at Cadence, said: “Our collaboration with ISI enables Cadence to generate electronic submissions leveraging our internal expertise, while technical infrastructure and integrity are fully supported by ISI.”
Rolando Sa, director of software services at ISI, said: “We enjoyed collaborating with Cadence because they share our vision for a better, more efficient drug application submission process. 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.”
ISI claimed that, using VMware’s virtualization system, its SaaS model provides life sciences organizations with a distinct and self-contained environment in order to maintain data protection, and 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.