Pharmacokinetics & Biostatistics

Qualified, trained & experienced team of statisticians, SAS programmers, pharmacokineticists, and medical writers providing high quality data analysis & statistical report writing in accordance with regulatory standards.

Pharmacokinetics:
  • Pharmacokinetics (PK) and Pharmacodynamic (PD) study designs
  • PK/PD modeling
  • Non-compartmental and compartmental, PK/PD, and population PK analyses
Biostatistics:
  • Sample size and power calculations
  • Randomization schemes
  • Development of sophisticated statistical analysis plan (SAP) including Mock Tables, Listings and Figures (TLF's)
  • Statistical programming and data analysis for PK, PK/PD, efficacy, and safety endpoints
  • CDISC compliant SAS Export Package
  • Statistical consultation and education
  • Ad hoc and retrospective analyses