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Peace of Mind

We provide solutions that offer you peace of mind by helping you comply with ever-evolving regulatory requirements. Our staff of industry experienced pharmacists, nurses and data entry specialists have expertise in all facets of pharmacovigilance. Services include:

  • Post-marketing and clinical trial adverse event intake, review, evaluation and follow-up

  • Individual case safety report (ICSR) data entry into clients or our validated database

  • Electronic submissions

  • Medical literature surveillance

  • MedDRA and WHO drug coding

  • Global adverse event expedited reporting

  • Periodic report preparation

  • Data analysis and ad-hoc safety reports

  • Safety and clinical database reconciliation

  • Validated safety database