SERVICES

Biostatistics

Westat offers comprehensive biostatistical support for interventional and observational studies with a focus on Phase I to IV randomized controlled clinical trials and multisite investigations.

Westat’s expertise extends to comprehensive biostatistical support for interventional and observational studies, including Phase I to IV randomized controlled trials and multisite investigations.

Comprehensive Support

Our team’s years of combined expertise make for flexible, rigorous solutions to address end-to-end biostatistical needs. We provide data analysis methods for both interim and final analyses following established industry standards – pivoting to meet the needs of your study and reporting requirements at each stage of the process. Westat’s biostatistical services include:

Designing conventional and adaptive studies
Developing statistical sections of protocols
Calculating sample size/power
Conducting simulations to assess probability of trial success
Developing randomization procedures
Accounting for missing values and multiplicity adjustments
Preparing Statistical Analysis Plans
Preparing Clinical Data Interchange Standards Consortium (CDISC) data packages, including legacy data conversion
Programming Tables, Listings, and Figures (TLFs) for Clinical Study Reports (CSRs) and other interim reports
Providing support for Investigational New Drug application development for drugs and biologics
Preparing integrated summaries of safety and efficacy
Developing conference presentations and manuscripts
Providing statistical support for data monitoring committees
Designing data analysis methods for interim and final analyses, such as multivariate modeling of survival/time-to-event and repeated measures/longitudinal analyses, analysis of event rates, meta-analyses, and multiple imputation

Westat’s biostatistical work is performed following our standard operating procedures, providing rigor and credibility and established to comply with industry standards. Westat has been a proud gold-level member with the CDISC organization since 2017.