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
|SOURCE Image Solutions, Inc.|
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