Our Services

Global Clinical Monitoring and Communications, Inc.

Pharmacovigilance

  • Medical and safety monitoring
  • Safety surveillance
  • Signal detection/Signal evaluation
  • Risk strategy, risk assessment and risk minimization
  • Aggregate Report Writing (DSUR, PSUR/PBRER, RMP/RM)
  • Medical assessment of all safety related data (AEs, SAEs, SUSAR, AESI, etc.)

Medical Affairs

  • Medical oversight
  • Clinical protocol design
  • Study reports and publications contribution and review
  • Therapeutic area training and protocol training
  • Key opinion leader networking

Regulatory Affairs

  • Regulator submissions
  • Regulatory strategy
  • Medical writing
  • Submissions management