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ISI Bolsters Data Analytics Capabilities for Complete Suite of Submissions Outsourcing Services
Date:11/13/2007

Biometrics and CDISC Conversion Services Provide Single-Vendor Support for

Electronic Common Technical Document Submissions

WHIPPANY, N.J., Nov. 13 /PRNewswire/ -- Image Solutions, Inc. (ISI), a leading provider of software and services to streamline the drug development and regulatory approval process, today announced it has expanded its outsourcing services to include a broader set of data analytics capabilities. ISI now offers a complete regulatory submissions solution compliant with the electronic Common Technical Document (eCTD) guidance.

ISI's biometrics capabilities, enhanced through the recent acquisition of Zurich Biostatistics, Inc. (ZBI), now include conversion of clinical trial study data into the U.S. Food and Drug Administration's (FDA) preferred format called the Study Data Tabulation Model (SDTM). The SDTM was developed by the Clinical Data Interchange Standards Consortium (CDISC) and is expected to lead to greater efficiencies in clinical research and FDA review of submissions.

"ISI differentiates itself with a 15-year track record of quality submissions and 100 percent FDA acceptance on completed submissions, one of the most critical factors in deciding the outsourcing question," said Michael Palmer, ISI's vice president of biometrics solutions and co-founder of ZBI. "In addition to this successful outsourcing performance, ISI also has a stable management team and a history of financial strength, which further reassures our client that we have a stable, mature organization to work with them."

The SDTM guideline comes as companies pursue outsourcing not only as a key strategy for meeting the January eCTD deadline, but also as a way to reduce costs and increase efficiency during the regulatory submission and approval process. ISI provides a range of business process services for companies that either seek to outsource completely or to blend internal capabilities with ISI skills and resources to overcome sh
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SOURCE Image Solutions, Inc.
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