• Pre-approval Safety
  • Medical Monitoring
  • Post-market Pharmacovigilance

The Certus medical team performs all safety surveillance activities during pre-approval and post-marketing phases of your product’s lifecycle. With extensive experience in the preparation and review of clinical trial documents, the Certus PV medical team works with your company in the preparation of Phase 1 – Phase 3 study protocols, investigator’s brochures, DSMB management and preparation of the DSMB charter as well as medical review of clinical trial safety data. For medical monitoring, Certus PV can provide medical support to your clinical trial investigator sites and project teams, medical review and follow-up of SAEs, case narrative report writing and filing reports with regulatory authorities.   Furthermore, the Certus PV team performs ongoing safety profiling of your products through signal detection.

The Certus medical team performs all safety surveillance activities during pre-approval and post-marketing phases of your product’s lifecycle.
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