| Expedited Delivery |
Our statistical analysis services are solidly founded on a combination of sound analytical judgment, agile
modeling methods, and expert statistical programming, to support all phases of clinical development and
post-marketing support.
The Proof is in the Pudding. If support for your claims exists in the data, we will find it, apply the most
effective means of developing it, and serve it up in ways that make it readily defendable and routinely
reproducible. Our statisticians embrace your projects as joint stakeholders endeavoring to extract the most
reliable decision support information from the available data. No stone is left unturned in pursuing your core
business interests.
Our analysis teams specialize in creating strategic value for you by leveraging proven data-driven methods to
optimize study size allocations, statistical power, and project costs. Our reputation has been built on careful
planning, attention to detail, and expert modeling applications. Armed with reliable SAS programming and
qualification procedures, we are poised and well-equipped to bring attractively priced, full-service analysis
support to your clinical development and clinical pharmacology projects.
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Statistical Analysis Services
- Clinical endpoint and experimental design development
- Sample size and power for parallel, crossover and replicated designs
- Statistical Analysis Plan preparation
- Subject randomization using central and stratified adaptive methods
- Statistical analysis of clinical endpoints, statistical programming & validation
- Comprehensive ICH summary tables, figures, and listings generation
- 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 agency representation
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Pharmacokinetics & Pharmcodynamic Modeling
- PK analysis planning and optimal sampling strategies
- Tabulation, display, analysis and interpretation of concentration-time data
- Non-compartmental analysis (WinNonlin) -- PK and PD 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 and evaluation using iterative measures analysis
- Use of biomarkers for individual and population PK/PD analysis and interpretation
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| Timely Precision |
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| Insightful |
| Detail-oriented |
| Results-driven |
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| Key Process Values |
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Close collaborative consultation |
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Senior level oversight of all |
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deliverables and analysis content |
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Secure role-based document and |
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comments exchange portal |
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Expert representation in agency |
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meetings and peer review |
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| Contact Us |
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