• Project support for medical monitoring including
  - On-call Medical Monitor 24/7
  - Ensuring adherence to project protocols and clinical trials
  conduct standards
  - Providing medical review and approval or waiving for
  patient eligibility according to study protocol
• Ongoing review and analysis of safety and/or efficacy data
• Medical review of data coding (consistency, accuracy and logic)
• Preparation of patient case narratives (case evaluation)

SAE Management

• Medical surveillance of SAE (Serious Adverse Event)
  reporting and follow-up, including on-call 24/7 Medical
  Monitor coverage
• SAE reporting and follow-up
• Preparation of SAE narratives and causality assessments
• Handling and assessment of adverse events including preparation of CIOMS and MEDWatch Reports
• Maintaining and managing SAE database and SAE reporting to Sponsor
• SAE Reconciliation