Therapeutic Areas

Infectious Disease Clinical Development Expertise

Get your novel infectious disease vaccine or therapy to market faster.

Infectious diseases are a threat to global health and way of life everywhere. Time is of the essence when it comes to developing safe and effective infectious disease vaccines and treatments.  In addition to recent pandemic outbreaks caused by viral infections, more treatment-resistant bacterial and fungal infections are increasing.

If your goal is to mitigate emerging threats and advance human health, you need thoughtful planning and conduct for successful clinical development. Veristat’s scientific-minded, infectious disease experts are devoted to helping you navigate this critical and challenging landscape. Our teams have conducted over 350 projects for Infectious Disease treatments and vaccines.

Developing an infectious disease therapy? Let’s Talk.

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 deep experience executing vaccine trials, and are adept with rapid response to global pandemics that arise, such as the recent  COVID-19 response.

Veristat’s experts are poised to plan and launch your trials 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.
Ensuring post-market drug safety with Pharmacovigilance support

Case Study: Rapid Launch of a COVID-19 Vaccine Trial

At the onset of the COVID-19 pandemic response, a sponsor needed to quickly build their clinical trial database in order to start enrollment and randomization. Learn how we helped our client design and launch their trial plan in two weeks’ time, with patient randomization beginning the day of launch.