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Clinical Service Overview Process
Integrated Evidence

Clinical Service Powered by Evidence and Expertise

Data-driven clarity for complex regulations and clinical operations.

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Overview

RMP Based RWD

Conduct safety assessments based on RWD and perform RMP-based RWD studies in compliance with international standards (ICH M14).

RMP Based PMS

End-to-End PMS support across study design, IRB processes, database setup, monitoring, and reporting.

RMP Based PMS/RWD

RWD

  • RWD-Driven Safety Insights
  • RMP-Based Post-Marketing Strategy
  • Fit-for-Purpose RWD Research
  • ICH-M14 Global Harmonization
  • AI-based data standardization

PMS

  • One-stop PMS Support: PMS design → IRB → Contracts management → DB setup → Monitoring → Reporting.
  • Integrated Site Operations: SMO collaboration, dedicated CRC Support, efficient patient enrollment.
  • PMS PM is assigned to strengthen timeline and quality management.

Process

Business Handshake
1
Clinical experts with hands-on experience and data-driven insight systematically identify the sponsor’s goals and needs.
2
We design the most suitable clinical services and studies for the sponsor, providing strategic consulting along with budgeting and contracting. (General consulting available when needed.)
3
A Clinical PM is assigned, initiating accurate and reliable clinical services driven by data.

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