Early Phase Analytics

Early Phase Analytics

In addition to our research unit, we accurately collect, analyze, and interpret data from humans using industry-standard methods.

Analytics: Early phase quantitative methods

Early Phase Statistics
  • Specifically designed and cost effective for early phase studies
  • Streamlined, real-time safety monitoring approach to data analysis and reporting
  • Interim and final analyses are needed
  • Use standard FDA reporting requirements for early phase studies
  • CDISC formatting capabilities
Clinical Pharmacology
  • Standard and specialized PK/PD analyses
    • Standard
      • Non-compartmental
      • Compartmental
      • Inter-species scaling
    • Specialized
      • Population PK/PD
      • Physiologically based PK
      • Pediatrics
      • Sparse sampling
      • PK/PD simulation
  • Analysis, reporting, and file generation that meets FDA requirements
  • Industry-standard software
Bioanalysis
  • Extensive expertise in bioanalytical assay development and validation
    • Special populations (pediatrics)
    • Unique biological matrices
  • Strong partnerships with commercial laboratories for assay development
  • Critical review of validation and sample analysis reports to meet FDA guidance
  • Direct communication with bioanalytical laboratories for data transfer coordination and upload into EDC