Kendle’s Chinese affiliate receives quality certification

Contract research organization Kendle International Inc.‘s Chinese affiliate has received a certification that the company says highlights the quality and consistency of its operations in China.

The company said KendleWits, its Chinese arm, is the first global contract research organization (CRO) to achieve ISO 9001:2008 certification in the country, according to a statement from Kendle. That means an independent auditor has found that KendleWits’ quality management systems are up to international standards.

CROs contract with pharmaceutical firms to help them with clinical trials, drug development and data management–basically everything in the life cycle from a new drug’s conception to its approval by the Food and Drug Administration.

The certification could differentiate Kendle from competitors as the Chinese market for CRO services grows. To win certification, KendleWits’ had to go through a months-long process of applications, training, documentation, audits and inspections by technical teams, according to the statement.

The ISO standards are developed and published by the International Organization of Standards, a Switzerland-based nonprofit.

Receiving certification means that auditors found that KendleWits’ quality management system evaluates processes in terms of value added to customers, measures results and effectiveness of process performance and is committed to continual improvements based on objective analysis, according to the statement.

Kendle has operated in China since 1997.

Last month, Kendle reported its financial results for 2009, which took a hit as pharmaceutical companies cut back on research and development expenses. Profits fell 34 percent to $15 million, while revenue dropped 19 percent to $552 million. CEO Candace Kendle said at the time she expects the company to experience little-to-no growth in 2010, as the market for Kendle’s services remains soft. To help combat the downturn, the company cut hundreds of jobs last year.