• Services for Japanese Companies

    Comprehensive support from strategic planning to on-the-ground execution for successful overseas expansion.

    • Design and Operation Support for Global Clinical Trials
      End-to-end support from protocol design and regulatory strategy to local trial execution.
    • Consulting on US/EU Regulatory and Submission Strategies
      Guidance for aligning with regulatory requirements such as FDA and EMA standards, supported by experienced global regulatory negotiators.
    • Deployment of Local Project Managers / Monitors (CRA)
      Supply of experienced PMs and CRAs in the US, EU, and Asia who faithfully implement Japanese headquarters’ policies, quality standards, and trial timelines.
    • Overseas CRO Negotiation and Coordination from a Japanese Perspective
      Bridging contractual and operational gaps caused by cultural and business practice differences, ensuring smooth project execution.
    • Rapid Deployment via Multinational CRO Partnerships
      Flexible and adaptive development capabilities with minimal delays, even for sudden changes in trial requirements.
    • Regulatory Document Preparation and Training
      Practical training to develop in-house staff capable of preparing submissions meeting both domestic and international requirements.