Quality Assurance

  • inspection of pre-clinical study reports
  • quality control of protocols, CRFs, patient information, informed consents etc.
  • auditing of the practical performance of clinical trials
  • auditing in compliance with GMP (supplier audits)
  • advice with the implementation of QS-systems

As we write trial reports ourselves, we can easily identify potential weak points. Precise knowledge of the practical procedures provides a further asset.

Based on our experience and on the participation in several projects, we always propose pragmatical solutions which take into consideration the requirements as well as the internal processes and capabilities of the company.