Safety and Pharmacovigilance

Safety Reporting & Pharmacovigilance

Service offered :-
  • Eligibility Verification-Confirmation process
  • Medical consultations (e.g. eligibility criteria, protocol design, requirements and restrictions)
  • Review and analysis of safety listings and tables
  • Safety signal detection and analysis
  • Medical coding
  • Periodic Safety Reporting (DSUR and periodic line listings)
  • SAE/AE/ADR handling (collection, database entry and evaluation)
  • Identification of AEs of special interest and appropriate handling
  • Provision of CIOMS and/or MedWatch forms for all SAE reports within expected timelines
  • Registration with EudraVigilance
  • Overdose handling (collection, database entry and evaluation)
  • Pregnancy handling (collection, database entry and evaluation)
  • 24/7 safety surveillance - available to Investigators for all PV related questions
  • Peri-marketing PV services
  • Case processing
  • Medical Coding
  • Narration writing
  • Case assessments and Case review
  • Periodic Safety Update report writing