Trial Strategy And Design

Design Your Study for Efficiency and Success from the Start

GBC offers clinical trial strategy and design services compliant with International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) standards.   GBC assists with developing all necessary study materials based on agreed study design and assesses the necessary operational parameters for successful execution. GBC trial strategy and design services include:

Trial Feasibility Assessment (Existing Studies)

  • Impact of Inclusion and Exclusion Criteria
  • Availability of Target Subject Population
  • Likelihood of Subject Participation
  • Projected Subject Enrollment Rates
  • Assessment of Investigator Interest
  • Compatibility with Current Standard of Care
  • Required Clinical Site Capabilities and Infrastructure
  • Required Vendor Capabilities
  • Study Logistics
  • Local and Central IRB Issues
  • Financial Considerations
  • Competing Trials

Trial Design (New Studies)

  • Study Design
    • Study Groups
    • Target Cohort Size for Biostatistical Significance
    • Inclusion and Exclusion Criteria
    • Logistical Design
  • ICH-GCP Compliant Clinical Study Protocols and Amendments
  • Model Patient Informed Consent Forms (ICFs)
  • Case Report Forms (CRFs) and Instructions
  • Clinical Trial Management Plans, including:
    • Clinical Site Development and Management Plan
    • Data Management Plan
    • Biospecimen Management Plan
    • Monitoring Plan

For Further Information On:

For additional information on GBC's clinical trial services please contact trials@globalbioclinical.com or register and send us your inquiry here.