A selection of "Good Clinical Practices" (GCP) projects:
- 2011-2012 - Concept of clinical data archiving and quality controlled process
- 2011 - Retrospective Validation of an EDC system in a CRO
- 2009 - Validation of a functional enhancement of a custom developed Pharmacovigilance system
- 2004-2008 - Several projects for validation of drug safety systems
- 2006 - Consulting for SOPs in biometrics
- 2005-2006 - Validation of the three systems of human pharmacological station
- 2003-2005 - Establishment of an IT-QMS in a CRO with subsequent validation of a clinical database
- 2001-2002 - Validation audit and subsequent validation support in the field of Clinical Data and Biometrics'
- 1999-2001 - validation consulting in a DMS project for the entire R & D process with electronic signatures
- 1999 - Project Manager for 2 teams (CH and U.S.) on migration and archiving of GCP data