Post-marketing

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.)