Agile Vaccine Clinical Development Expertise

Understanding Vaccine Trials

We understand that vaccine development has a unique set of challenges, so Veristat has assembled an extraordinary team of scientific-minded experts who have planned and executed over 140 vaccine projects and supported numerous marketing applications.  

Whether a vaccine to prevent or treat cancer recurrence or progression, or rapidly responding to an infectious disease outbreak, like the ongoing COVID-19 pandemic, we solve the problems that arise in testing immunotherapy vaccines, live or inactivated viral vaccines, or even the newest DNA vaccines.

At Veristat, our experienced teams are poised to plan and implement these efforts quickly providing:     

• Development of regulatory strategy, expedited pathways, and regulatory agency interactions
• Clinical program planning, inclusive of statistical planning and analysis 
• Agile patient recruitment strategies to support virtual trial and hybrid approaches
• Rapid deployment of clinical trial databases  
• Virtual and remote clinical and medical site monitoring 
• Data analysis and migration into CDISC formats
• Writing of clinical trial, safety, and regulatory documents
• Preparation and defense of Marketing Applications – NDAs, BLAs, NDSs, MAAs, jNDAs, etc.