Over the past 10 years Coastal Carolina Research Center has been audited by the following entities:
FDA Audits
March 2007 – PI: Cynthia Strout, MD – The FDA reported no findings at the conclusion of the audit.
November 2001 – PI: Valerie Scott, MD – The FDA issued a 483. Sponsors and CROs may contact Nathan Morton at nmorton@coastalcarolinaresearch.com or 843/856-3784 for more information or a copy of the 483 and response.
Sponsors
Over the past 5 years Coastal Carolina Research Center has been involved in 7 internal sponsor audits. All final reports were favorable.
Bertek – April 2002
Novartis – August 2003
GSK – February 2004
Sanofi Aventis – January 2006
Barr/Duramed – January 2007
CROs
Over the past 10 years CCRC has been involved in multiple CRO audits. All final reports were favorable.
IRB
CCRC was also contacted and audited by a IRB in 2003. This was not for cause however was due to the IRB’s SOPs which required them to visit audit a certain # of research sites. All final reports were favorable.
Copernicus IRB - 2003
