SERVICE

Post-marketing Surveillance (GPSP)

Providing High-quality CRO Service

We have the longest history
in Japan and are a proven brand in post-marketing surveillance

We are the CRO with the most experience in project management of post-marketing surveillance and offer full service ranging from study design to reexamination applications and compliance assessment support. We can accommodate all types of requests using our advanced IT, BPO, and PMS solutions as well as our well-established PMS service in Data Management and Biostatistics.

Post-marketing Surveillance (GPSP)

  • Study Planning
  • Patient Recruitment
  • EDC-enabled Data Management
  • Biostatistics
  • Medical Writing
  • Auditing / Self-inspection
  • IT Solutions
  • BPO Solutions
  • PMS Support Solutions

Pharmacovigilance (GVP)

  1. Progress Follow-up System ADDIN.SCOPE
  2. PMS-EDC ADDIN
  3. On-site CRO Service
  4. MR/Branch Office Progress Follow-up
  5. Trial Sites Contract
  6. Preparing Study Planning and Implementation Guidance
  7. Preparing Draft of Entry Forms and CRFs
  8. Reexamination Application
  9. Conformity Audits Support
  10. PMS Monitoring
  11. PMS Call Center
  12. Distribution Management Support

Services Provided for Post-Marketing Surveillance (GPSP)

NEW

ADDIN EX

Our EDC System provides speed,
low cost and high quality