Kendle, a global full-service clinical research organization, has 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.
