A full service Contract Research Organization

Offices in the San Francisco Bay Area and Sydney, Australia

Strategic Consulting

Our team has years of experience in planning and executing clinical trials as well as, analyzing and reporting clinical data to approval. Our experts provide hand on advice that range from study design to drug approval. InClin has a proven track record of providing a focus approach to solving unique challenges. Some examples of where InClin can assist with strategy and planning include:

CLINICAL TRIAL OPTIMIZATION

InClin has developed a unique service for sponsors that have a need to improve the performance of on-going studies without the need to replace the existing CRO. These processes follow our core principles of project management and proven success in optimizing several large phase 3 global clinical trials for sponsors using both regional and global CROs.

  • Robust process which analyzes project progress against the intended project plan
    • Identifies risks, issues, problems, work around solutions, and opportunities
    • Includes interviews with project personnel at sponsor, CRO and specific sites
    • Complete review of project plan and key documents
  • Make actionable recommendations to
    • Accelerate timelines
    • Realign budget
    • Refocus project scope
  • Interactive collaboration between InClin and sponsor’s internal project team
  • Enables continuous evaluation of project performance and objective outcomes

EXPERIMENTAL DESIGN AND PROTOCOL DEVELOPMENT

InClin has expertise in the design of simple to complex clinical trials. We utilize our cross departmental approach working with the client to ensure the design is robust and has the highest probability of success. Types of studies we have designed include:

  • Adaptive designs and simulation analysis to duplicate the ultimate study condition and assess the potential outcome
  • Parallel Designs (e.g., superiority, non-inferiority)
  • Crossover (Bioequivalence, Food Effect)
  • Dose escalation (e.g., 3×3 or 6×6 and MTD designs)
  • Repeated Measures
  • Sequential Designs
  • Study Design
    • Objectives
    • Endpoints
    • Alpha Spending Scheme (e.g., Hochberg, Westlake, Closed Testing)
  • Analyses (e.g., standard, non-standard, modeling, etc.)
  • Sample Size Estimation (EAST, PASS11, nQuery)