PPD estimated its projected 2009 revenues in the range of $1.595 to $1.670 billion, an increase of approximately 12 percent. The company expects diluted earnings per share for the full year 2009 to be approximately 18 percent higher. “We believe PPD is well-positioned to deliver solid financial results in 2009,” said Fred Eshelman, CEO. “Our 2009 financial guidance demonstrates our confidence in the core development business, and we plan to continue to focus our efforts on sales execution and operational excellence throughout the year.” Here’s the release.

CTI Clinical Trial and Consulting Services announced that it is upgrading and expanding its use of Oracle applications for clinical development to support the company’s continued growth in the U.S. and global markets. CTI has recently upgraded to the newest releases of the Oracle suite, include its products for data management, safety, and electronic data capture. “We invested in Oracle’s clinical applications suite from the very start of our organization because it is a leader that has the confidence of the biotech and pharmaceutical industry. Over the years, Oracle has been very flexible and eager to work with our emerging organization, playing an important supporting role in continued growth,” said Kevin Schwarz, senior VP, clinical trial operations. Here’s the release.

The New York Times cites a new report from Washington, and Congressional frustration that the FDA has a comparatively relaxed level of regulatory scrutiny for medical device manufacturers. One key issue is how much real review is given to the most commonly implanted devices, in Class III. “The agency laid out a plan in 1995 to write those rules but never followed through, the accountability office found. The result is that most Class III devices are still approved with minimal testing,” the newspaper notes in this article.

Parexel International appointed Josephine Hoppe as corporate VP and CIO. She’ll be managing the company’s information technology (IT) initiatives and integrating technology solutions with business processes. “Parexel ‘s unique position as both the leading eclinical solutions provider, through our subsidiary Perceptive Informatics, and as one of the world’s largest users of these technologies, is an important differentiator in the value we are able to deliver to clients,” said Josef von Rickenbach, chairman and chief executive officer of Parexel International. “We look forward to Jo’s innovation and leadership in helping Parexel to achieve the strategic information management objectives of the company and its clients.” Here’s the release.

Kendle opened a second office in western India in the city of Ahmedabad, further expanding its presence in the country and acting on its plans for continued growth in the Asia/Pacific region. Kendle has operated in New Delhi, India, since 2004 and is targeting additional expansion in India in 2009 to meet customer needs. “Expansion in the Asia/Pacific region, and India in particular, is essential to our continued success as a top global CRO,” said Candace Kendle, chairman and CEO. “Our increased presence and capacity in the region will allow us to better meet the needs of our customers who are seeking to capitalize on India’s cost-effective, yet high-quality clinical research capabilities to develop their compounds.” Here’s the release.

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