What can DaneStat offer you and your business?
The types of services offered are detailed, although given the evolving nature of drug development I also provide advice on novel approaches to drug development. Please contact DaneStat Consulting for more information.
- Protocol Development, including power and sample size calculations and Statistical Analysis Plan authoring.
- Expertise and experience in antibiotic trial design, and novel approaches to antibiotic development.
- Clinical Trial and Clinical Program Design, including decision making criteria and risk assessment to choose optimal program designs
- Statistical analysis of clinical trial data
- Statistical input and authoring of regulatory agency briefing documents or submission documents
- Statistical representation at regulatory authority meetings
- In-licensing and due diligence support