Infectious Disease Clinical Development Expertise

Experience Battling Infectious Diseases

Whether you are aiming to prevent or combat a viral, bacterial, fungal or parasitic infection, Veristat can help make the difference for your study’s success. Our teams understand the nuances and difficulties involved with treating infectious diseases, have the experience to perform vaccine trials, and are adept with rapid response to global pandemics that arise, such as the current COVID-19 outbreak response.   

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.