Legacy of Regulatory Submissions Leadership Strengthened with Clinical
Trials Services and Standards-Based Data Management
WHIPPANY, N.J. and ATLANTA, Sept. 6 /PRNewswire/ -- Image Solutions, Inc. (ISI) announced today it agreed to terms to acquire Zurich Biostatistics, Inc. (ZBI). With the Life Sciences industry moving to standards-based regulatory submissions, the acquisition further strengthens ISI's Clinical Data Interchange Standards Consortium (CDISC) capabilities, the FDA-supported standard for clinical trials data and metadata.
"The FDA's embrace of CDISC standards presents pharma and biotech companies with a once-in-a-decade opportunity to streamline processes and harmonize operations with submissions," said Jinsoo Kim, ISI president and chief executive officer. "Our portfolio of clinical trials services gains instant experience and credential with the acquisition of ZBI."
ZBI and its president, Michael Palmer, pioneered the development and implementation of CDISC-based regulatory submissions. Palmer has co-authored and contributed to CDISC standards since 2000. He will continue at ISI as vice president of biometrics, overseeing the company's CDISC products and services.
"Over the next year, the FDA will rapidly move towards data standardization as a way to expedite innovation and bring new drugs to market faster and more effectively, an issue the industry is finding much more difficult then it was five years ago," said Palmer. "The health and well-being of millions of people is at stake -- the streamlining of drug development has never 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 hinges on the analyses of biometrics data. With clinical trials costing drug sponsors hundreds of millions of dollars, failed submissions can be detrimental. By adding highly qualified and experienced statisticians and programmers, ISI is able to help clients create statistical plans, conduct analyses and assist in the preparation of reports to avoid these pitfalls. Companies are also able to achieve more effective collaboration between statisticians and medical writers, speeding time to final CSR.
ZBI's core capabilities in biometrics analysis support ISI's commitment to complete, holistic regulatory submissions. Existing clients of both ISI and ZBI now have instant access to this approach and capability.
ISI is a pioneer in modernizing the regulatory submission process. The company enabled the first-ever electronic new drug application to the FDA and is at the forefront of the industry's move to adopting the electronic Common Technical Document (eCTD), the new drug application standard that will be required by the FDA at the end of 2007.
About Image Solutions, Inc.
Founded in 1992, Image Solutions, Inc. (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firm to deliver electronic submissions to the industry and since has delivered more than 1,000 electronic submissions and 400 eCTD submissions. ISI serves the 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 U.S., 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 over 20 recognized charitable organizations. For more information, visit the company Web site at http://www.imagesolutions.com.
Lisa Meyer Kurt Rossler
Director, Global Marketing M Booth & Associates
973-560-0808 x. 217 212 481-7000
|SOURCE Image Solutions, Inc.|
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