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