Expert Biostatistics Services for Clinical Trials
Our biostatistics team provides comprehensive statistical support for all phases of clinical development. From protocol design to regulatory submissions, we ensure robust statistical methodologies that meet regulatory requirements and support successful trial outcomes.
Our PhD-level statisticians and SAS programmers deliver accurate, reliable statistical analysis that forms the foundation of your regulatory submissions and decision-making processes.
We specialize in complex statistical designs including adaptive trials, Bayesian methods, and innovative study designs. Our team stays current with evolving regulatory guidelines from FDA, EMA, and other global health authorities, ensuring your statistical approaches meet the highest standards of scientific rigor and regulatory compliance. We provide clear, actionable insights that drive confident decision-making throughout your clinical development program.
Frequently Asked Questions
Q: What statistical software do you use?
A: We primarily use SAS for regulatory submissions, complemented by R, Python, and other specialized statistical software as needed. Our team is certified in SAS programming and maintains expertise in all current versions, ensuring compatibility with regulatory agency requirements.
Q: Do you provide CDISC SDTM and ADaM datasets?
A: Yes, we specialize in CDISC standards including SDTM mapping, ADaM dataset creation, and define.xml development. Our biostatisticians work closely with data management teams to ensure seamless integration and validation of CDISC-compliant datasets ready for regulatory submission.
Q: Can you support adaptive trial designs?
A: Absolutely. Our team has extensive experience with adaptive designs including sample size re-estimation, group sequential designs, and Bayesian adaptive methods. We provide statistical analysis plans, simulation studies, and independent statistical analysis for data monitoring committees.
Our Biostatistics Services Include
- Statistical analysis plan development
- Sample size calculation and power analysis
- Randomization schema development
- Statistical programming and analysis
- TLF (Tables, Listings, Figures) generation
- Clinical study report statistical sections
- CDISC SDTM/ADaM programming
- Regulatory submission support
