Pharmacovigilance

Patients come first.
Stay on top of patient protections with better pharmacovigilance.

Detect, assess, understand, and prevent adverse effects and other treatment-related problems — enhance patient care and safety with pharmacovigilance.

Monitor your project within a robust safety system, and ensure consistent communication with safety experts. Quartesian’s expert resources work with your team to create a well-designed safety management plan (SMP) for tests related to medicine testing and usage.

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Safety Management Plan

  • SMP creation and coordination
  • Outline study safety activities and processes
  • Define roles, responsibilities, workflow, templates, and actions for safety management

Safety Database

  • Create a safety database apart from the clinical trial database
  • Record safety data received by the safety department
  • Reconcile safety data with clinical adverse event data
  • Create and maintain safety database based on study-specific protocol
    • In conjunction with client’s Data Management team

Serious Adverse Event Collection and Safety Reporting

  • Define overall procedures for the collection, evaluation, and reporting of SAEs
    • Prior to first site initiation
  • Receive specific details on SAE flow in a safety management plan
    • Reviewed and signed by both client and Quartesian
  • Process each SAE, evaluate for medical accuracy, and enter into the safety database
  • SAEs coded in compliance with CRF coding

Overall Medical Monitoring

  • Therapeutic area/indication training of project teams
  • Medical support for project staff and the investigator sites
  • Monitor overall study conduct and safety
  • Evaluate patient eligibility and determine the need for waivers, as needed
  • Provide causality assessment for all SAEs
  • Coding (MedDRA, WHO Drug) of adverse event information
  • Review and resolution of protocol issues

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