Providing Pharmacovigilance Service From Clinical Trials to Post-Marketing Stage

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

Services

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 cases100% case quality control (QC)
Data entry, MedDRA coding, Creating a NarrativeDrafting of follow-up queries
Pre-assessment (unexpectedness, regulatory reportability)Preparation of e-Files (ICSR File, J item File, Report Form for PMDA/CIOMS/Sponsors, etc.)
Translation Service (Japanese ⇔ English ⇔ Chinese)Literature Screening

Correspondence and management of safety information according to Japanese regulations

Safety Writing (aggregate reports)  and  Creating Other ReportsConsultation for Safety Issues
Japanese Periodic Safety Report/Reexamination Application Document/ Infection Disease Periodic Safety Report/Create local and global SOP
Research Report/Report of Measures in Foreign CountryEducate and train safety specialists on regulatory requirements
PSUR, DSURJapanese Safety Regulatory Requirement
Translation of Safety information and other related materials (Japanese⇔English)Japanese Safety Regulatory Requirement

Consulting Services

In-Country Clinical Caretaker (ICCC)

Project Management

Clinical Operations

Data Management

Statistical Analysis

Quality Assurance

Clinical Operations

Medical Writing