q Integrated development strategies

q Adaptive trial design and design evaluations via clinical trial simulation

q Dose and regimen comparison through the application of drug & disease modeling

q Early go / no go model-based decision support

- Modeling of pooled proprietary data

- Modeling to benchmark against competitor drug data

- Quantify the probability of inferior, equivalent, or superior product profiles

q Translational pharmacology: leverage preclinical PK/PD and toxicokinetic data to estimate the likely clinical dose for a new compound

q Program and portfolio reviews

q Independent assessment of key go / no-go decisions

q Quantitative assessments (including uncertainty assessments) of current product profiles

q Preclinical Pharmacokinetic (PK) analysis & reporting

q Toxicokinetic analysis & reporting

q Inter-Species allometric scaling

q Inter-Species Pharmacodynamic (PD) scaling

q Clinical Trial management

q Phase 1-2 Pharmacokinetic / Pharmacodynamic (PK/PD) and reporting

q Clinical study reporting, including TLF programming in a validated SAS™ and R programming environment and report writing

q Manage regulatory communications and filings in the US and EU