- Drug and CDx co-development
- Bridging studies
- Follow-On studies
- Analytical studies
- Accuracy studies
- Regulatory and Submissions
- Support for full publication circle
- Full bioinformatics solutions
- Customized methodology development and application
- Survival and longitudinal data analysis
- Real world evidence (RWE) analysis
- Meta-analysis
Why Statistical Design Excellence Matters
Clinical trial success hinges on robust statistical design from inception through regulatory submission. Poorly designed studies not only waste resources but can lead to inconclusive results, regulatory delays, or missed opportunities to bring life-saving treatments to patients. At Vista Statistics, we understand that each phase of clinical development requires specialized statistical expertise, tailored methodologies, and regulatory-compliant approaches that maximize the probability of success while ensuring patient safety.
Our statistical designs are built on decades of regulatory science experience, incorporating the latest methodological advances and regulatory guidance from FDA, EMA, and other global authorities. We design studies that generate compelling evidence packages capable of supporting regulatory approval and market access decisions.
