Clinical Research

  • Submissions
    for more than 20 years ethics committee and health authority submissions for all study phases (I-IV)
     
  • Site selection
    face to face site validations in the listed indications
     
  • Contracts
    long-term experience in contract negotiation (including implementation of master agreements)
     
  • NIS (non interventional studies)
    since 2006 implementation and conduct of several registries and non interventional studies (including submission to the Ethics Committee and Health Authority)
     
  • Audits/Inspections
    15 years of experience in preparation, conduct of audits and inspections (including FDA) as well as implementation of corrective and preventive action plans
     
  • ICH/GCP Training
     
  • Medical Affairs
    long-term experience