Audit and Inspections

Inspection of study BI 1220.7, carried out by the US Food and Drug Administration (FDA), 

31. March to 3. April 2014.

 

Study audit for Bionor Vacc-4x IMiD/-2010/1, 

initiated by CRO Aptiv Solutions, 7 and 8 November 2013.

 

Study audit on A4001095, initiated by the sponsor Pfizer,

14. and 15. May 2013.

 

Study audit on GS-US-264-0106, initiated by the sponsor Gilead Sciences,

21. and 22. November 2011.

 

Study audit on ING114467, initiated by sponsor GlaxoSmithKline, 

12. and 13. October 2011.

 

Study audit on BI 1100.1486, initiated by sponsor Boehringer Ingelheim, 

1. April 2009.

 

Inspection of the study BI 1182.107, carried out by the State Office for Health and Social Affairs, Berlin

June/July 2008.

 

Study audit on AI 424-138 (CASTLE), initiated by sponsor Bristol-Myers-Squibb, 

November 2006.

 

GCP audit of the WV16789 study, initiated by the sponsor ROCHE, 

Mai 2004.

 

Study audit on BI 1182.52, initiated by sponsor Boehringer Ingelheim, 

January 2003.

 

GCP audit of the APV 30005 study, initiated by the sponsor GlaxoSmithKline, 

October 2002.