ClinTrialStat Statistical Analysis Services combines sound analytical judgment, agile modeling methods, and expert statistical programming to support all phases of clinical development.

ClinTrialStat Analysis Teams specialize in creating strategic advantages for you and your company through careful planning, attention to detail, and expert modeling applications. Armed with reliable SAS programming, qualification procedures, and powerful technology made available through SapMaker Content 2.0 and SapMaker Table 3.4. Due to this advantage we are poised and well-equipped to bring attractively priced, full-service analysis support to your clinical development and clinical pharmacology projects.

Statistical Analysis Services

Clinical endpoint and experimental design development.
Sample size and power for parallel, crossover and replicated designs.
Preparation for Statistical Analysis Plans
Subject randomization using central and stratified adaptive methods
Statistical analysis of clinical endpoints, statistical programming & validation
Comprehensive generation of ICH summary tables, figures, and listings
Meta analysis and mixed-effects modeling
Submission support, including preparation of safety & efficacy summaries (ISS/ISE)
Interim analysis and reporting
Exploratory analysis, ad hoc and custom data summaries
Regulatory guidance and liaison support with regulatory agencies
 

Pharmacokinetics and Pharmcodynamic Modeling

Pharmacokinetics analysis planning and optimal sampling strategies
Tabulation, display, analysis and interpretation of concentration-time data
Non-compartmental analysis (WinNonlin) -- Pharmacokinetics and Pharmodynamic analysis
Compartmental PK/PD Modeling and Simulation (WinNonlin or NONMEM)
Parametric/Nonparametric Population PK/PD Analysis and Simulation (NONMEN)
Individual and population bioequivalence analysis
Modeling and simulation of diverse dosing and sampling strategies
Steady-state determination, evaluation and analysis using efficient iterative measures
Use of biomarkers for individual and population PK/PD analysis and data interpretation