Quality and data integrity services

Fuglsang Pharma provides audit services under the following primary standards

  • OECD GLP - Good Laboratory Practice
  • 21CFR58 - Good Laboratory Practice (US version)
  • ICH E6 - Good Clinical Practice

Technical GCP/GLP assistance to National Agencies is offered via WHO.

The SaToWIB, Roaster VIII, Effiou and Buster routines for fraud detection in clinical trials were invented and programmed by Anders Fuglsang. All rights retained. They have been and are in current use by agencies. They are available to private companies as well. They are characterized by a high detection rate and a low rate of false positives. The statistical approach underlying the software is described in the European Journal of Pharmaceutical Sciences. Click here to access the paper.