Safety assessment and reporting

KCRI provides safety reporting services including, but not limited to:

  • Serious Adverse Events management including reporting to the appropriate Regulatory Bodies in accordance with regulations and local requirements,
  • Preparation and updates of Safety Management Plan,
  • Support in obtaining/renewal of MedDRA license,
  • MedDRA/CTCAE coding,
  • Support in registration in EudraVigilance database,
  • Management of medicinal product information in XEVMPD,
  • Preparation and submission of periodic reports to the appropriate Regulatory Bodies,
  • Providing medical monitoring coverage,
  • Medical device vigilance