Safety in Clinical Trials

  • Case management from receipt, data entry, narrative writing, possible follow up, medical assessment, quality control to electronic reporting
  • Design of the quality system, including Safety Management planning, SOPs, conventions and standards
  • Validated safety database available
  • Periodic reports (DSURs, linelistings, ad hoc report)
  • Data Safety Monitoring Boards
  • Support in ongoing benefit/risk management, including PV signal evaluation, review of protocols and interpretations of results
  • Assistance with urgent requests from regulatory authorities