Biostatistics

Our expert biostatisticians apply scientific principles and therapeutic indication knowledge to support you throughout the entire clinical development process. Biostatistics is at the heart of every clinical study—driving study design, study conduct, data collection, analysis and reporting—and our biostatisticians work closely with the entire project team throughout the study to ensure that the correct data is captured and ready for analysis.

Our Statistical Experience

We have extensive experience providing biostatistical consulting services from study design and protocol development to study analysis through regulatory submission and agency meeting representation.  Our statistical experience includes pre-clinical, clinical, registration phase, and post-marketing studies.

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Explore Our Biostatistic Services

  • Study design  
  • Protocol development
  • Strategic statistical consulting
  • Sample size calculations
  • Endpoint development
  • Randomization schemes
  • Statistical analysis plans (SAP)
  • Adaptive Design
  • Statistical tables, data listings, and figures for clinical study reports (CSRs)
  • eCRF design and review
  • Statistical analyses and reports
  • Pharmacokinetic and pharmacodynamic analyses
  • Regulatory Submissions - Regulatory guidance, planning, and meeting representation
  • Integrated safety and efficacy analyses (ISS/ISE/ISM)
  • Data Monitoring Committee (DMC) services
  • SDTM and ADaM datasets (submission ready dataset packages)

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