Our services span from preclinical strategies to commercialization support.
Some of our expertise include:
Statistical Programming: Generating SEND & SDTM datasets; SAS programming; creating tables, listings and figures for clinical study reports and regulatory submissions.
Translational Modeling & Simulations: Quantitative integration of nonclinical pharmacology, DMPK and toxicology data for clinical PKPD projection and first-in-human dose recommendation.
Pharmacometrics: Population PKPD modeling and exposure-response analyses of clinical endpoints for optimal dose selection, rational trial designs, PK/efficacy/safety covariate analyses and regulatory submissions.
Commercialization Support: Market assessment and product forecasting, new product development strategy and product life cycle management.