Our Expertise

statistical consultants
  • Our biostatisticians apply scientific knowledge to support you. Biostatistics is at the heart of every clinical study.
  • They work closely with the entire project team throughout the study. For example, they ensure that the correct data is captured and ready for analysis.
  • We have extensive experience providing biostatistical consulting and services. For example, our biostatistical experience includes pre-clinical, clinical, registration phase, and post-marketing studies.
  • We support the planning and biostatistical analysis of your clinical trial and regulatory submissions projects.

Our Services

Clinical Data Management

We are happy to provide the help you need at any or all of the following steps in earning the data-based answers you request:

  • Study design
  • Protocol development
  • Strategic statistical consulting
  • Sample size calculations
  • Endpoint development
  • Randomization schemes
  • Statistical analysis plans (SAP)
  • Adaptive Design clinical trial planning, simulation, and implementation
  • 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 dataset preparation (submission-ready dataset packages)

Contact Us 24/7 for a Free Consultation

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