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"The FDA's embrace of CDISC standards presents pharma and biotechcompanies with a once-in-a-decade opportunity to streamline processes andharmonize operations with submissions," said Jinsoo Kim, ISI president andchief executive officer. "Our portfolio of clinical trials services gainsinstant experience and credential with the acquisition of ZBI."
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ZBI and its president, Michael Palmer, pioneered the development andimplementation of CDISC-based regulatory submissions. Palmer has co-authoredand contributed to CDISC standards since 2000. He will continue at ISI as vicepresident of biometrics, overseeing the company's CDISC products and services.
"Over the next year, the FDA will rapidly move towards datastandardization as a way to expedite innovation and bring new drugs to marketfaster and more effectively, an issue the industry is finding much moredifficult then it was five years ago," said Palmer. "The health and well-beingof millions of people is at stake -- the streamlining of drug development hasnever been more important."
ISI's acquisition of ZBI also bolsters the company's new biometrics'service line. Securing FDA approval on new drug submissions frequently hingeson the analyses of biometrics data. With clinical trials costing drugsponsors hundreds of millions of dollars, failed submissions can bedetrimental. By adding highly qualified and experienced statisticians andprogrammers, ISI is able to help clients create statistical plans, conductanalyses and assist in the preparation of reports to avoid these pitfalls.Companies are also able to achieve more effective collaboration betweenstatisticians and medical writers, speeding time to final CSR.
ZBI's core capabilities in biometrics analysis support ISI's commitment tocomplete, holistic regulatory submissions. Existing clients of both ISI andZBI now have instant access to this approach and capability.
ISI is a pioneer in modernizing the regulatory submission process. Thecompany enabled the first-ever electronic new drug application to the FDA andis at the forefront of the industry's move to adopting the electronic CommonTechnical Document (eCTD), the new drug application standard that will berequired by the FDA at the end of 2007.
About Image Solutions, Inc.
Founded in 1992, Image Solutions, Inc. (ISI) is a proven market leader inproviding submissions solutions, process services and consulting to LifeSciences companies as a way to improve clinical and regulatory processes thatbring new medicines to market. ISI was among the first professional servicesfirm to deliver electronic submissions to the industry and since has deliveredmore than 1,000 electronic submissions and 400 eCTD submissions. ISI servesthe top 50 pharmaceutical and biotech organizations as well as the topcompanies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jerseyand operations throughout the U.S., Europe and Asia. ISI also remainscommitted to giving back to society and sharing its success with others bydonating 10 percent of annual net profits to over 20 recognized charitableorganizations. For more information, visit the company Web site athttp://www.imagesolutions.com.Press Contacts: Lisa Meyer Kurt Rossler Director, Global Marketing M Booth & Associates 973-560-0808 x. 217 212 481-7000 [email protected] [email protected]
