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PK/Statistics Review

Data that speaks science.

Our pharmacokinetic and statistical experts ensure your study design, analysis, and interpretation are accurate, regulatory-compliant, and publication-ready.

PK Study Design Review

Sample points, washout, and analysis windows.

Bioequivalence Calculations

Cmax, AUC, Tmax, 90% CI.

Population PK Modeling

Advanced compartmental and non-compartmental models.

Interim Data Review

Early detection of trends or anomalies.

Statistical Analysis Plans (SAPs)

Regulatory-compliant documentation.

Dataset QC & Validation

CDISC SDTM/ADaM formats.

Regulatory Submission Tables & Listings

FDA and EMA formats.