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BIOSTATISTICS
TRIAL DESIGN, REPORT POPULATION & CAPABILITIES
RCRI provides full service statistical support for your study needs. Our goal is to help you obtain robust conclusions from your clinical trial. All RCRI biostatisticians have graduate degrees in the field, a wealth of experience, and diverse backgrounds including positions in industry, academia, and government. RCRI statisticians are well versed in a wide variety of techniques, tools and applications.
Our goal is to bring our clients into the analysis process from the start so that they fully understand the business risks associated with various designs and techniques.
Maximizing Return on Investment
Trial Design
Clinical trials are expensive. They have to be designed to have the power to satisfy FDA’s demands; but over-enrollment can lead to delayed market entry. In order to save you money, we will help you determine the minimum sample size required to power a clinical trial adequately. We can also employ a number of techniques that allow trials to be analyzed early, which can save our client millions of dollars.
Automatic Report Population
Once the trial ends, and the results are known, the submission date is often delayed while the clinical report is compiled. The basic problem with most statistical software is that results cannot simply be “pasted” into the clinical report template in a validated fashion. RCRI can save you considerable expense and reduce project timelines with our internal tools that transfer statistical output directly to the reports.
Biostatistical Capabilities
RCRI will:
- Determine the optimum trial design approach:
- Frequentist/sequential
- Bayesian/adaptive analysis
- Calculate sample size
- Develop an analysis plan
- Negotiate with the FDA and other regulatory agencies regarding the proposed sample size, statistical approach, and analysis techniques.
- Serve on the DSMB or as a liaison to the DSMB
- Automate the generation of annual/interim/final clinical reports
- Write the summary report and the statistical analysis section of scientific papers
- Defend trial results to FDA
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