Study Implementation

During the term of a clinical trial, the following services are rendered (no exhaustive list):

• Preparation and distribution of the study documents
• Randomisation / registration
  SAE/SUSAR Management
• Preparing and obtaining approval from the competent/accompanying Ethics Committee in case of subsequent content-related or formal modifications
• Preparation and submission of Annual Safety Reports (ASRs) to the competent federal authorities including obtaining approvals of subsequent modifications
• Scientific and operative support to the trial centres
• Monitoring
• Follow up