Clinical Trial Analysis
Our combined experience covers the statistical analysis of over 100 clinical trials in multiple therapeutic areas.
Biostatistics
We provide biostatistical analysis of phase 2/3/4 clinical trials. Therapeutic areas in which we have experience include asthma/allergy, antiviral, antibiotics, oncology, metabolic, arthritis/pain, and others. Please contact us for more details.
We can also review your analysis/study reports prior to FDA submission. With two former FDA reviewers, we can provide the reviewer perspective on your clinical submissions.
Protocol Design
We've written/reviewed hundreds of protocols and statistical analysis plans (SAP's) across the range of study designs and indications.
Janet Elashoff is a leading expert on sample size / power analysis, and is the creator of nQuery, the most widely used commerical power analysis software.
