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CINCINNATI, March 23 /PRNewswire-FirstCall/ -- Kendle (Nasdaq: KNDL), a leading, global full-service clinical research organization, today announced Drew Kilpatrick, PhD, Director, Global Safety and Pharmacovigilance, has been named one of ten "Notable People in R&D" by leading industry publication R&D Directions. Dr. Kilpatrick was selected based on his pioneering work in developing TrialEAS™, a practical Web-based solution that enables independent adjudication of clinical endpoints and assists investigators in selecting appropriate patients for enrollment into clinical studies. TrialEAS™ recently was honored as the "Best Technological Development in Clinical Trials – Software Solution" at the 2009 Clinical Research Excellence Awards sponsored by Good Clinical Practice Journal.
"We are so pleased that R&D Directions has recognized the groundbreaking and innovative nature of the work completed by Dr. Kilpatrick and his team," said Stephen Cutler, PhD, Senior Vice President and Chief Operating Officer. "As regulatory authorities increase requirements for endpoint driven studies to confirm morbidity, mortality or safety, it becomes ever more crucial to develop solutions that reduce costs within the clinical development process without compromising patient safety or clinical judgment. With TrialEAS™, Dr. Kilpatrick's team has introduced a versatile Web-based solution that fulfills these requirements."
Kendle's TrialEAS™ can save customers both time and expense by streamlining the adjudication process. The modular system is integrated with a Web-based portal to allow seamless receipt of patient source documents and/or images from investigator sites anywhere in the world. Because TrialEAS™ enables real-time access and transmission of these source documents, it also speeds their translation from local languages into English, a major obstacle to efficient review. By allowing independent adjudicators to review all necessary documents online, the system all but eliminates the travel and expense required for face-to-face adjudication meetings and reduces the risk of over enrollment. Kendle recently has expanded TrialEAS™ functionality to assist investigators in selecting appropriate patients for enrollment into clinical studies, and the system can be adapted to facilitate any medical review requiring the vote of independent adjudicators.
"I am honored to have been named to this prestigious list," said Dr. Kilpatrick. "By deconstructing and reengineering the traditional adjudication process, we have automated much of the time- and labor-intensive paper-based system traditionally used for these studies. I am particularly pleased to have solved the issue of efficient translation of source documents thereby removing them from the critical path of independent adjudication. Our team continues to examine clinical development processes to improve both efficiency and patient safety."
Dr. Kilpatrick joined Kendle in 2006 and oversees the day-to-day operations of the Company's Safety and Pharmacovigilance teams in Europe and Asia/Pacific. He has nearly three decades of experience in clinical development and process improvement and is a global thought leader in the field of endpoint adjudication. Dr. Kilpatrick was instrumental in developing Kendle's risk management team, which assists customers in developing risk management plans to satisfy U.S., European and other regulatory authority requirements.
The R&D Directions editorial staff selected the 2010 "Notable People in R&D" from industry-submitted nominations based on the innovative nature of each nominee's work. Each honoree must have made "significant or lasting contributions to their field, whether in fundamental drug discovery and development or process-driven clinical trial management." The selection of Dr. Kilpatrick marks the third time the publication has named a Kendle expert to their "Notable" list. In 2009, Edward Sellers, MD, PhD, Vice President, Early Stage, was chosen for his work in human abuse liability studies. In 2007, William Sietsema, PhD, Vice President, Regulatory Consulting and Submissions, was chosen for the publication's first-ever "Notable People in R&D" list based on his work in innovative trial design.
For the full R&D Directions profile on Dr. Kilpatrick please visit the Kendle Web site at http://www.kendle.com/uploads/ePrintRDD1.pdf.
About Kendle
Kendle International Inc. (Nasdaq: KNDL) 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 from the use of Kendle's TrialEAS™ Web-based solution 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 March 23, 2010. 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.
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"We are so pleased that R&D Directions has recognized the groundbreaking and innovative nature of the work completed by Dr. Kilpatrick and his team," said Stephen Cutler, PhD, Senior Vice President and Chief Operating Officer. "As regulatory authorities increase requirements for endpoint driven studies to confirm morbidity, mortality or safety, it becomes ever more crucial to develop solutions that reduce costs within the clinical development process without compromising patient safety or clinical judgment. With TrialEAS™, Dr. Kilpatrick's team has introduced a versatile Web-based solution that fulfills these requirements."
Kendle's TrialEAS™ can save customers both time and expense by streamlining the adjudication process. The modular system is integrated with a Web-based portal to allow seamless receipt of patient source documents and/or images from investigator sites anywhere in the world. Because TrialEAS™ enables real-time access and transmission of these source documents, it also speeds their translation from local languages into English, a major obstacle to efficient review. By allowing independent adjudicators to review all necessary documents online, the system all but eliminates the travel and expense required for face-to-face adjudication meetings and reduces the risk of over enrollment. Kendle recently has expanded TrialEAS™ functionality to assist investigators in selecting appropriate patients for enrollment into clinical studies, and the system can be adapted to facilitate any medical review requiring the vote of independent adjudicators.
"I am honored to have been named to this prestigious list," said Dr. Kilpatrick. "By deconstructing and reengineering the traditional adjudication process, we have automated much of the time- and labor-intensive paper-based system traditionally used for these studies. I am particularly pleased to have solved the issue of efficient translation of source documents thereby removing them from the critical path of independent adjudication. Our team continues to examine clinical development processes to improve both efficiency and patient safety."
Dr. Kilpatrick joined Kendle in 2006 and oversees the day-to-day operations of the Company's Safety and Pharmacovigilance teams in Europe and Asia/Pacific. He has nearly three decades of experience in clinical development and process improvement and is a global thought leader in the field of endpoint adjudication. Dr. Kilpatrick was instrumental in developing Kendle's risk management team, which assists customers in developing risk management plans to satisfy U.S., European and other regulatory authority requirements.
The R&D Directions editorial staff selected the 2010 "Notable People in R&D" from industry-submitted nominations based on the innovative nature of each nominee's work. Each honoree must have made "significant or lasting contributions to their field, whether in fundamental drug discovery and development or process-driven clinical trial management." The selection of Dr. Kilpatrick marks the third time the publication has named a Kendle expert to their "Notable" list. In 2009, Edward Sellers, MD, PhD, Vice President, Early Stage, was chosen for his work in human abuse liability studies. In 2007, William Sietsema, PhD, Vice President, Regulatory Consulting and Submissions, was chosen for the publication's first-ever "Notable People in R&D" list based on his work in innovative trial design.
For the full R&D Directions profile on Dr. Kilpatrick please visit the Kendle Web site at http://www.kendle.com/uploads/ePrintRDD1.pdf.
About Kendle
Kendle International Inc. (Nasdaq: KNDL) 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 from the use of Kendle's TrialEAS™ Web-based solution 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 March 23, 2010. 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.
