Global Clinical Development

Advancing your candidates through successful global clinical trials

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Assistance in:

• Formulation and guidance on efficient global clinical development strategy
  • Overall global clinical development plan based on your end goal (commercialization vs. licensing)
  • Recommendation of most efficient strategy for balancing speed, quality and cost
  • Other considerations for successful global development
• Efficient global clinical trial execution
  • Recommendation for clinical study design
  • Sourcing of "best fit" CROs
  • Development of well designed Request-for-Proposals (RFPs)
  • Introduction and evaluation of CROs and their bids
  • Management of the global studies on behalf of the Sponsors
  • Liaison with the CRO during the study period
• Preparation of materials and documents suitable for application for global clinical trial authorizations
  • Review of the Korean application documents
  • Generation of English documents including
    • Protocol
    • Investigator Brochures
    • IMPD (Investigational Medicinal Product Dossier)
    • Informed Consent
    • Patient diaries and other materials