Prompt post-marketing phase vigilance and post-marketing surveillance for fast, efficient solutions.

Post-marketing Phase Solutions

  • Advice/ document preparation for risk management plan
    • At application for approval
    • In response to inquiry
    • In pre-marketing phase
    • At application for revision
  • Advice/ document preparation for early post-marketing phase vigilance
    • Protocol development
    • Data collection method
    • Report preparation
  • Advice/ document preparation for safety information processing
    • Advice/ document preparation for periodic reporting of infectious diseases, periodic reporting of unknown non-serious events, periodic reporting from clinical trial, etc.
    • Information disclosure, etc.
  • Advice on selection of CRO for outsourcing
  • Advice/ document preparation for GVP,GPSP and protocol
  • Storage and management of various data
  • Tasks related with use result survey (special use result survey)
    • Development of protocol for survey
    • Response to all-patient surveillance order
    • Development of SOP and CRF
    • Response to inquiry on protocol
    • Procedure for data collection
    • Statistical analysis plan
    • Periodic report
    • Final report
    • Response to inquiry on periodic report and final report
    • Schedule management and publication methods
    • Preparation for application for re-examination
    • Application for re-examination
    • Tasks related with compliance inspection
  • Advice/ document preparation for other materials (medication guide, patient guide, kusuri-no-shiori, brochure on medication, etc.)
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