Clinical Research Biostatistics for Your GI Program
Our expert statistics team covers:
Study design & simulation
Input on study design, endpoint confirmation, and design performance checks using simulated data
Statistical planning
Development of statistical analysis plans (SAPs), randomization and stratification schemes, and robust strategies for handling missing data
Adaptive design
Planning and execution of interim analyses and adaptive trial design alternatives that have pre-specified rules
Submission readiness
Traceable, CDISC-compliant programming (SDTM/ADaM) with time-tested processes and quality control (QC) that stands up to regulatory inspection
Pharmacokinetics and Pharmacodynamics (PK/PD)
Our PK/PD work gives sponsors what they need most: clarity, confidence, and precision in dose selection.
Modeling That Drives Decisions
We apply noncompartmental and compartmental analyses, population PK, and exposure–response modeling to illuminate variability and sharpen your development path. Whether you’re navigating bioavailability/bioequivalence, drug–drug interactions, or special‑population considerations, our team of experts ensures your decisions are grounded in robust, regulatory‑aligned analytics.
