Consulting

We can help and support you with the following issues:

  • Labelling of study medication according to the EU Directive 2001/20/EC and the local requirements
  • Submission of medical device and drug studies to Competent Authorities
  • Submission of medical device and drug studies to Ethics Committees
  • Protocol and CRF development according to the national regulations, ICH/GCP and ISO 14155:2011
  • Arranging patient insurance coverage for study patients
  • Translation of study documents such as Patient Information Forms and Informed Consent Forms into the German / Dutch / French / Czech/  Slovakian languages
  • Implementation of national requirements into Patient Information Forms and Informed Consent Forms
  • Providing in-house training to study teams of investigational sites and sponsors