SFBC International Inc. Data Table I

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 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. The final entry in Table 1 for principal investigator Stephen Scheinman M.D. contains an obvious error in the BMIS file Receipt Date field (01-Jan-1900). FDA doesn't update the Site and Address fields every time new entries are created. This is the likeliest explanation why Dr. Kenneth Lasseter's Site and Address fields contain an older study site and address (Clinl Pharm Assoc and 2060 NW 22ND Ave) instead of the new address at SFBC International Inc. on Biscayne Boulevard in Miami.

Table 2: FDA IND drug studies approved by the LeeCoast Research Center Institutional Review Board

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

Rev. ID = REVIEWER ID: (6-digit number).

LAST NAME: The last name of the clinical investigator or the IRB chairperson. This field allows a maximum of 23 characters. This field will contain an NG (Not Given) for CROs, and for IRBs if no name is found.

FIRST NAME: The first name of the clinical investigator or the IRB chairperson. This field allows a maximum of 13 characters. This field will contain an NG for CROs, and for IRBs if no name is found.

MI = MIDDLE INITIAL: The middle initial of the clinical investigator or IRB chairperson, if given. It is a 1-character field.

RANK: A 3-character field for name qualifier (e.g., JR, SR).

Deg. = DEGREE: The educational degree given for the clinical investigator or IRB chairperson. It is a 6-character field.

SITE: For a clinical investigator, this is name of the site of the study, or of the business of the investigator. For an IRB or CRO, it is the name of the organization. It is a 100-character field.

STREET ADDRESS: This is the address of the site named above. If a clinical investigator does not have a study or business site given, it will be the home address. It is a 36-character field.

CITY: The city location of the address given above. It is a 14-character field.

STATE: The 2-letter state code. NG is used for foreign addresses.

ZIP CODE: The 5-digit zip code plus the 4 digit extension if known.

Co. = COUNTRY: The letter country code.

RECEIPT DATE: The date the source document (1572, etc.) was received by FDA. It is a 9-character field in the format DD-MMM-YYYY.

TYPE: A 3-character field that designates the entry:

• Clinical Investigator (DEM)
• Contract Research Organization (CRO)
• Institutional Review Board (IRB)

Source: FDA Bioresearch Monitoring Information System (BMIS) File. U.S. Food and Drug Administration Division of Scientific Investigations. Available from http://www.fda.gov/cder/foi/special/bmis/index.htm Accessed 2005-11-15.

Notes

1. There are 377 entries in Table 1; each entry represents a study conducted under FDA IND regulations at 21 CFR 312. Table 1 includes investigators at SFBC International Inc. (Miami, FL) and at subsidiaries SFBC Fort Myers Inc. (formerly LeeCoast Research Center) and Clinical Pharmacology Associates, acquired by SFBC International Inc. on 2003-08-13. Sources: SFBC International Inc. Management Team (Phase I/IIA Services). SFBC International Inc. web site. Available from http://www.sfbci.com/sfbc/SFBC/client/en/AboutUs/Management.asp?id=3. Florida Department of State, Florida Division of Corporations. Available from http://www.sunbiz.org/corpweb/inquiry/search.html. Accessed on 2005-11-25.

This information is intended to be read with the Bloomberg News story titled Big Pharma's shameful secret (With interviews and updates). David Evans, Michael Smith, and Liz Willen. Bloomberg News Special Report. 2005-11-08. Available from http://www.bloomberg.com/specialreport/bigpharma.html, or in PDF from http://www.bloomberg.com/specialreport/pharma.pdf. Accessibility verified 2006-03-28.

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Last Updated: 2006-04-28

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