CBS is committed to patient safety and is ready to collaborate with clients to meet the increasingly complex regulatory requirements in pharmacovigilance. Our full range of services offer flexible technologies, resourcing solutions, effective governance and continuous process improvement from early clinical development to marketed product support. Through efficiencies, maintaining quality and adhering to regulations, CBS creates value across all areas of pharmacovigilance. CBS’s offers pharmacovigilance services:

  • PV Consultancy
  • Serious Adverse Event Case Processing of Initial/Follow-up reports
  • MedDRA coding
  • Medical Monitoring
  • Global Expedited Case Reporting
  • Safety Data Management & Global Safety Database
  • Development Safety Update Report (DSUR) preparation and submission
  • Global Literature Search & Review in support of the DSUR
  • Pharmacovigilance Quality Assurance including SOP development
  • Monthly compliance and status reporting
  • Pharmacovigilance Awareness Training
  • Reconciliation of Serious Adverse Events
  • Risk Management
  • Study documentation review and update, including protocol and Investigator’s Brochure