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"Regulatory authorities increasingly are requiring marketing applicants and marketing authorization holders to undertake endpoint-driven studies, typically involving thousands of patients across the globe, to confirm the morbidity, mortality and safety profile of their products. Traditionally, adjudication has used a paper-based approach creating both time and cost implications for those undertaking these studies," said Stephen Cutler, PhD, Kendle Senior Vice President and Chief Operating Officer. "Kendle's TrialEAS(TM) solution is a Web-based electronic system that expedites the on-line review of documents, scans and other medical materials by independent adjudicators, replacing the paper-based process and providing earlier confirmation of morbidity/mortality benefits of investigational medicinal products or products already on the market." Dr. Cutler continued, "We are pleased to have been recognized by such a distinguished panel with this prestigious award, and look forward to implementing this innovative solution to enhance patient safety and deliver additional time and cost savings for our customers."
The "Best Technological Development in Clinical Trials - Software Solution" category was judged based on which product represented the best advance in supporting clinical trial management. Kendle's TrialEAS(TM) system was nominated for its innovation in streamlining the adjudication review process. The modular system is integrated with a Web-based portal to allow seamless receipt of patient source documents and/or images from sites anywhere in the world. By allowing independent adjudicators to review all necessary documents online, TrialEAS(TM) all but eliminates the need for face-to-face review, resulting in substantial time and cost savings. The innovative system was originally designed for endpoint adjudication, but also is now used to make patient inclusion/exclusion decisions and may be adapted for any medical review requiring the vote of independent adjudicators.
Kendle's receipt of the "Best Technological Development in Clinical Trials - Software Solution" award follows other recent industry recognition received by the Company. In June 2009 Kendle was named among the "Top CROs to Work With" in the CenterWatch 2009 survey of U.S. investigative sites, receiving the highest ratings of any CRO in providing "Patient Recruitment Planning and Implementation Assistance." Kendle is the only CRO to be ranked consistently among the top two CROs to work with in the 2009, 2008 and 2007 CenterWatch surveys of U.S. and European investigative sites. The "2009 CRO Quality Benchmarking Report" published in March by Industry Standard Research rated Kendle as delivering the "Most Consistent Quality Services" and also rated the Company highest among CROs for "CRA Quality," "Efficient Site Start-up" and "Meeting Project Timelines."
About Kendle
Kendle International Inc. (Nasdaq: KNDL | Quote | Chart | News | PowerRating) is a leading global clinical research organization providing the full range of early- to late-stage clinical development services for the world's biopharmaceutical industry. Our focus is on innovative solutions that reduce cycle times for our customers and accelerate the delivery of life-enhancing drugs to market for the benefit of patients worldwide. As one of the world's largest global providers of Phase I-IV services, we offer experience spanning more than 100 countries, along with industry-leading patient access and retention capabilities and broad therapeutic expertise, to meet our customers' clinical development challenges.
Additional information and investor kits are available upon request from Kendle, 441 Vine Street, Suite 500, Cincinnati, OH 45202 or from the Company's Web site at www.kendle.com.
Forward-Looking Statements
Certain statements and information contained in this press release may be deemed to be forward-looking statements under federal securities laws and the provisions of the Private Securities Litigation Reform Act of 1995 and Kendle intends that such forward-looking statements be subject to the safe-harbor created thereby. All such forward-looking statements, including the statements contained herein regarding anticipated trends in the use of Kendle's TrialEAS(TM) solution and other such solutions, are based largely on management's expectations and are subject to and qualified by risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those risks as detailed from time to time in Kendle's Annual Report on Form 10-K as well as periodic reports filed with the SEC. All information in this press release is current as of Oct. 21, 2009. The Company undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company's expectations.
SOURCE Kendle International Inc.
http://www.kendle.com
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