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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