Resources and Services
Services
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Biostatistics, Epidemiology and Research Design
Support for study design, data collection and management, statistical analysis, interpretation of results and reporting
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Regulatory Knowledge Support
Guidance on regulatory-enabling documents, Institutional Review Board (IRB) submissions and Investigational New Drug (IND) application design
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Pharmacokinetics/ Pharmacodynamics
Assistance with study design, data analysis, PK modeling, simulation and PK/PD correlation to optimize drug development and research findings
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Research Ethics Consultation
Support for participant selection and recruitment, research with special populations, informed consent processes and ethical considerations in research studies
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