Outsourcing Clinical Trial Materials - Pharmaceutical Technology

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Outsourcing Clinical Trial Materials
CROs and CMOs expand to gain a piece of the market for clinical trial materials.


Pharmaceutical Technology
Volume 33, Issue 6, pp. 48-52

Global CRO expansions




The globalization of clinical trials is an important consideration for contract research organizations (CROs) that provide clinical management and related support. Since 2002, the number of active investigators regulated by the US Food and Drug Administration based outside the United States has increased 15% annually while the number of US-based investigators has declined by 5.5%. (1). Approximately one-third of the trials (157 of 509) are conducted solely outside the US, and a majority of study sites (13,521 of 24,206) are outside the US, based on a recent analysis of industry-sponsored Phase III clinical trials for the 20 largest US-based drug companies as of November 2007 (1). Another analysis shows significant growth in global trials, with Africa, the Middle East, Eastern Europe, and South America topping the list of regional expansion (2).

To keep pace, the major CROs are expanding into developing nations. In April 2009, PPD (Wilmington, NC) acquired AbCRO, a CRO operating in Central and Eastern Europe. The acquisition gives PPD entry into Romania, Bulgaria, Serbia, and Croatia. In October 2008, PPD acquired InnoPharm (Smolensk, Russia), a CRO providing Phase II–IV clinical trials support, data management, and biostatistics services in Eastern Europe. InnoPharm has offices in Moscow and St. Petersburg, Russia, and Kiev, Ukraine. PPD also opened an office in Istanbul, Turkey, in 2008. To meet demand in Southeast Asia, PPD is expanding its global central laboratory services in Singapore. It also formed a pact in 2008 with Peking Union Lawke Biomedical Development to expand its global central laboratory services in China.

In April 2009, Covance (Princeton, NJ) opened clinical-development offices in Santiago, Chile, and Lima, Peru, and expanded its Buenos Aires, Argentina office. In February 2009, Covance opened clinical development offices in Kiev; Bratislava, Slovakia; and Tel Aviv, Israel. Covance is planning to build a preclinical facility in China. The company had originally planned to build the facility as part of a joint venture with the CRO WuXi AppTec (Shanghai), but announced in September 2008 that it would no longer pursue the project jointly and would instead build its own preclinical facility in China.

In other CRO global expansions, Quintiles Transnational (Research Triangle Park, NC) is expanding with a new regional headquarters in Singapore, which is scheduled to be completed in the third quarter of 2009. It is also adding a Phase I clinical unit in Hyderabad, Andhra Pradesh, India, recently opened an office in Jakarta, Indonesia, and expanded offices in Manila, Taipei, Seoul, Kuala Lumpur, Bangkok, Sydney, and Hong Kong. Parexel (Boston) opened an office in November 2008 in Lima to provide regulatory-consulting and clinical-research capabilities. And in 2008, Charles River Laboratories (Wilmington, MA) opened a 60,000-ft2 preclinical facility in Shanghai.

Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072,

References

1. S. Glickman et al., "Ethical and Scientific Implications of the Globalization of Clinical Research," N. Eng. J. Med. 360 (8), 816–823 (2009).

2. P. Van Arnum, "Globalizing Drug Development," Pharm. Technol. Sourcing and Management, Mar. 2008, http://PharmTech.com/ptsm/, accessed May 12, 2009.


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