Services include 

• Consulting service for conducting a Clinical Investigation or Post-CE Mark Study in Germany and/or Austria - find the best strategy in alignment with processes and timelines
  
• Conducting submissions and obtaining approvals from German and Austrian Competent Authority (BfArM/BASG) and Ethics Committees
• Conducting submission and obtaining approvals from the German Radiation Agency (Bundesamt für Strahlenschutz)
• Assist in Clinical Investigational Plan (Protocol) development
• Patient Informed Consent development and review
• Assist in site selection and site assessment
• Development of guidelines, procedure