Our biostatistics department complies with all FDA and European regulatory requirements. In addition to statistical analysis of clinical trial data, our biostatistics consultants provide expert and creative support for clinical trial design, sample size calculations, and the defense of statistical strategy at meetings with FDA and other regulatory authorities. We have experience working on more than 100 projects from Phase I to Phase IV, and more than 30 recurring clients, which include start-up as well as large pharmaceutical companies.
Biostatistical Core Services:
- Statistical Consulting for product development and regulatory defense
- Clinical trial randomization services
- Sample size calculation / Power calculation
- Statistical Writing for Protocols
- Statistical Analysis Plan (SAP) Writing
- Programming and Performance of Statistical Analysis
- Performance of Interim Statistical Analysis
- Statistical Report Writing
- Methods and Results Writing for Scientific Papers
- Integrated Summaries of Safety and Efficacy
- DSMB support and participation
We can also assist you in all stages of your clinical study, not just the statistical analyses. Let our statisticians assist you during the start-up phase of your program. We can provide advice on study design, choice of endpoints, hypothesis composition, and number of subjects needed for the required power.
Our statistical analyses are performed using industry standard software, and our GCP-compliant SOPs guarantee high quality results. Your results are presented in a statistical report describing the analyses performed and include an interpretation of the results.