Pharmacovigilance

Our specialized staff can provide prompt and precise support for dealing with adverse event/ reaction information for your investigational and marketed drug products. We can provide a wide range of services: Case Processing & Reporting, Literature Screening, Periodic Reporting, Medical Device Vigilance, Pharmacovigilance Consultation.

Our Edge in Pharmacovigilance

Staff with expertise from the pharmaceutical industry

• Our staff has expertise on medical or pharmaceutics from the pharmaceutical industries (domestic or international), nurses, pharmacists, clinical technologists, physical scientists and chemical scientists etc.

Ability to provide service to meet the customer needs

• We can flexibly provide wide range of PV support services in conventional pharmacovigilance activity and comprehensive PV operation

Case Processing & Reporting (Pharmaceuticals, Medical Device and Regenerative Medicine) for clinical trials, post-marketing surveillance and spontaneous reports (domestic or foreign)

• Receipt and triage of initial and follow-up cases
• Data entry, MedDRA coding, creating a narrative
• Pre-assessment (unexpectedness, regulatory reportability)
• Translation Service (Japanese – English – Chinese)
• 100% case quality control (QC)
• Drafting and follow-up queries
• Preparation of e-Files (ICSR File, J item File, Report Form for PMDA/CIOMS/Sponsors, etc.)
• Literature Screening
• Medical Review

Correspondence and management of safety information according to Japanese regulations