Phase Iib-III Clinical Trials - Biostatistics

Regulatory experience. Precise analyses.

PharmaNet biostatisticians have a broad knowledge base in all aspects of clinical trials, from sample size calculation and design specifications during planning stages, to analyzing, displaying and interpreting data in the final stages of the study. In addition, PharmaNet’s biostatistics team has significant regulatory experience, which can help facilitate smooth regulatory submissions. PharmaNet experts plan the analyses you’ll need before the study begins, then provide reports, statistical summaries, and efficacy and safety analyses promptly and accurately as the study progresses.

Biostatistics clinical research services include:

• Protocol development, including sample size and power calculations
• Randomization schedules
• Statistical analysis plans
• Statistical programming in SAS^®
• Statistical analyses using current methodologies
• Interpretation and reporting of data for clinical trial reports and publications
• Regulatory representation
• Interim analysis and DMC support
• Database integration (ISS/ISE preparation)