MEDIA RELEASE PR38747
Kendle is First Global CRO to Achieve ISO 9001:2008 Certification in China Through
Beijing Affiliate
CINCINNATI, Mar. 16 /PRNewswire-AsiaNet/ --
Recognition validates Company's focus on quality and consistency of operations
in emerging regions
Kendle (Nasdaq: KNDL), a leading, global full-service clinical research
organization, today announced its affiliate in China, Beijing KendleWits Medical
Consulting Company Ltd. (KendleWits), has obtained ISO 9001:2008 certification from
the International Organization for Standardization, validating the quality and
consistency of its operations in this growing region. Through KendleWits, Kendle is
the first global CRO to achieve ISO 9001:2008 certification in China, reaffirming the
Company's strong position as an experienced clinical development partner for
customers developing new medicines in this crucial market. Dr. Xie Yan Bin, General
Manager, KendleWits, was presented with the certification during a formal ceremony at
the Contract Research Organization Union annual meeting.
"I am extremely proud of the KendleWits team for achieving this prestigious
certification," said Candace Kendle, PharmD, Chairman and Chief Executive Officer.
"As we continue to build our presence in emerging markets, we are keenly focused on
quality. ISO 9001:2008 certification reinforces our ability to provide our customers
with the highest-quality early- to late-stage clinical development services anywhere
in the world while remaining focused on their needs for innovative and efficient
solutions that expedite the development process. Dr. Xie and her team have
demonstrated the ability to deliver best-in-class clinical development services in
one of our most important markets."
ISO is a global organization that encourages companies and organizations to adopt
standards and processes for developing, implementing and improving effectiveness of
quality management systems. ISO 9001:2008 certification involves a months-long
process of applications, training, documentation, audits and inspections by ISO
technical teams. Certification means that the ISO has found that KendleWits' quality
management system consistently recognizes the importance of understanding and meeting
customer requirements; evaluating processes in terms of value added to customers;
measuring results and effectiveness of process performance; and committing to
continual improvements based on objective analysis.
"We are so pleased to have accomplished ISO 9001:2008 certification," said Dr.
Xie. "This certification further demonstrates our unmatched commitment to quality and
the exceptional level of service we provide to our biopharmaceutical customers. We
are continuously focused on delivery, quality and efficiency to meet and exceed
customer expectations and prepare for the growing drug development opportunities here
in China."
Kendle was one of the first global CROs to enter China when it began operations
in Beijing through its KendleWits partnership in 1997. KendleWits offers full-service
clinical development capabilities and has completed numerous global Phase I to IV
trials. The KendleWits team is recognized internationally for its quality research
and Good Clinical Practice (GCP) training initiatives.
Kendle has a longstanding presence in the Asia/Pacific region. In addition to its
KendleWits affiliate in Beijing, Kendle operates offices in Ahmedabad and New Delhi,
India; Hong Kong and Shanghai, China; Kuala Lumpur, Malaysia; Bangkok, Thailand;
Manila, Philippines; Singapore; and Sydney and Melbourne, Australia.
Growth in Asia remains a crucial part of Kendle's overall business strategy. The
Asia/Pacific region, especially China, is recognized as the world's fastest-growing
area for clinical research. Industry analysts at PricewaterhouseCoopers have
estimated that the Chinese CRO market will grow at a compounded growth rate of 33
percent in the near future, reaching as much at $791 million by the end of 2012.
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
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 benefits of ISO 9001:2008 certification 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 15, 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.
CONTACTS: Michael Lawson,
Investors,
+1-513-763-1992,
Lori Dorer,
Media,
+1-513-345-1685,
both of Kendle
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