Medical Affairs

Medical Monitoring, Safety Management and Pharmacovigilance

• Around-the-clock, continuous physician coverage
• Involved in all aspects of clinical trial design including identifying study populations, key efficacy and safety parameters and treatment
• Serious Adverse Event (SAE) processing
• SAE narratives, MedWatch, Analysis of Similar Events (AOSE)
• Protocol-related interactions with Investigators
• Development of detailed, sponsor-specific management plans
• Medical coding
• Global SAE reporting to regulatory agencies – both expedited and routine
• Reconciliation of SAEs to AE Data
• Medical review of trial Data, Investigator Brochures and study Protocol
• Medical writing of safety sections for study Protocols, periodic Safety Reports and Clinical Study Reports (CSR)
• Patient eligibility review and consultation
• Protocol exception and violation tracking and management
• DSMB activities