Premier Research’s biostatisticians understand that sound data analysis is the key to reliable clinical trial results and provide statistical approaches tailored to your study objectives. Our biostatisticians work with clients to determine the optimal method for collecting, analyzing, and presenting data while maintaining compliance with regulatory guidelines. Our programmers create customized tables, optimized for unique study designs. Solid statistical data analysis depends on careful planning, and a statistician is involved throughout the lifespan of a project. 

Maximizing Efficiencies
Premier Research utilizes the Parallel Processing Approach™ (PPA). PPA has been established in-house for a number of years and successfully implements cost-effective high quality, rapid execution of biometrics study tasks.

Designs

Frequentist

Adaptive

Equivalence

Noninferiority

Superiority

Methods

Descriptive statistics and univariate analyses

Linear and nonlinear models

Generalized linear models based on maximum likelihood

Categorical data analysis

Event time distribution models

Nonparametric and mixture models

Imputation/patterns of missingness

Monitoring

Bayesian

Conditional power

Stochastic futility

Services

• Study Design
• Sample Size Calculation
• Statistical Methods for Protocols
• Protocol and CRF Review
• Randomization Schedules
• Statistical Analysis Plans
• Interim Analysis
• Statistical Programming
• Table, Listing, and Figure Generation

Expert Services

• FDA Consulting
• Clinical Development Planning
• Exploratory Analysis
• Large-Scale Data Intergration
• Integrated Safety and Efficacy Analyses (ISS/ISE/CTD)
• Data Monitoring Committee Support
• E-Submissions
• CDISC Compliant Datasets
• Independment Programming Verification
• Manuscript and Presentation Preparation
• Marketing Support