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SFBC International Inc. Data Table II

Table 2: FDA IND Drug Studies Approved by the LeeCoast Research Center Institutional Review Board ( 1 )

Source: FDA Bioresearch Monitoring Information System (BMIS) File (current through 2005-09-30). U.S. Food and Drug Administration Division of Scientific Investigations. Available from (External) http://www.fda.gov/cder/foi/special/bmis/index.htm . Accessed 2005-11-15. An asterisk (*) indicates a blank field in the FDA Bioresearch Monitoring Information System (BMIS) File. The BMIS file includes information on drug studies conducted under FDA Investigational New Drug (IND) applications only. Bioequivalency studies conducted for generic drug marketing approvals are not included.

Key: FDA Bioresearch Monitoring Information System (BMIS) File fields

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Table 3: FDA IND Drug Studies Conducted at SFBC International Inc., Miami and Approved by the Southern Institutional Review Board Inc.

Notes

1. There are 86 entries in Table 2. LeeCoast Research Center Institutional Review Board was purchased by SFBC International Inc. in early 2001. According to SFBC International Inc., Barrie Phillips Ph.D., president and CEO of SFBC Fort Myers:

… formed LeeCoast Research Center, Inc. in December 1992 and became its President and Chief Executive Officer. The company had its own Institutional Review Board, and conducted Phase I-IV clinical trials. In late 1996, LeeCoast Research Center merged with ClinSites, a newly formed SMO. Early in 2001, LeeCoast was acquired from ClinSites by SFBC International and was renamed SFBC Fort Myers. Doctor Phillips currently serves as President of SFBC Fort Myers.

Source: SFBC International Inc. Management Team (Phase I/IIA Services). SFBC International Inc. web site. Available from (External) http://www.sfbci.com/sfbc/SFBC/client/en/AboutUs/Management.asp?id=3 . Accessed on 2005-11-25.

It seems likely that the LeeCoast Research Center Institutional Review Board came along with its founder Dr. Phillips when SFBC International Inc. acquired LeeCoast Research Center Inc. There are no records in the Florida Division of Corporations database to indicate the LeeCoast Research Center Institutional Review Board was independently incorporated and it doesn't appear to be registered as a fictitious business name. FDA regulations are silent on the corporate status of institutional review boards. Source: Florida Department of State, Florida Division of Corporations. Available from (External) http://www.sunbiz.org/corpweb/inquiry/search.html . Accessed on 2005-11-25.

Last Updated: 2006-03-28

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