Services

Drug Development Services

The center will provide both consultation and technical work product services. Areas of consultation are:

• Scientific and logistical assessment of research objectives and operations
• Design of experiments and surveys
• Design of clinical trials
• Regulatory aspects of research and development of pharmaceuticals
• Protocol development
• Sample size calculations
• Treatment code and group assignment strategy
• Clinical development plans and/or regulatory strategies
• Statistical analysis plans
• Statistical methods
• Database design and implementation
• Data management
• Data collection, instrument design and development

Areas of technical, work product, services are:

• Design experiments, surveys, clinical trials and protocols
• Provide clinical development plans and/or regulatory strategies
• Provide statistical analysis plans and statistical sections of protocols, New drug Applications (NDAs), Supplemental New Drug Applications (SNDAs), Premarket Approval Applications (PMAs) for medical devices, and Product Licensing Applications (PLAs) for biologics
• Design and develop data collection instruments
• Design and implement databases
• Provide data management, oversee and/or perform data entry
• Develop SAS computer programs for statistical analysis
• Perform statistical analysis
• Provide interim and final documents reporting the results and interpretation of experiments, surveys and clinical trials
• Conduct simulation techniques
• Conduct Monte Carlo methods of approximation, including MCMC and Gibbs Sampler

Pricing information:

For the consultation and service charges, please contact the Center for Biostatistics.