Biostatistics
Our biostatisticians are well versed in all aspects of Phase I-IV trials and can provide continuity throughout the life of the program. Our biostatisticians use the latest version of SAS (v9.1) demonstrating both our expertise in the utilization of the industry “Gold Standard” statistical software as well as our proficiency in meeting client needs. SAS® software is used for all statistical analysis. All programming is done in the development environment and all programs are tested before they are released for production. Early development of study specific programs facilitates quick delivery of the results after database closure.
We can provide the following biostatistical services in support of your clinical trials on a routine basis:
- Study design
- Sample size calculations
- Protocol review and consulting
- CRF review
- Randomization
- SAS® programming (PC SASR v9.1)
- Audited tables, figures and listings
- Interim and final analyses
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- Statistical reporting
- Clinical Study Report review
- Common Technical Document support
- Data Monitoring Committee (DMC) support
- Regulatory agency support and interaction including
FDA, EMEA, and other regulatory agencies
- Annual safety updates
- Consulting and training
- Database integration for integrated summaries
(CTD, NDA)
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