Solutions

Agile Vaccine Clinical Development Expertise

Accelerate vaccine development to prevent and treat virulent diseases

Vaccine developers worldwide are faced with the complex challenge of quickly and safely advancing their vaccines through the clinical development and approval process to prevent millions of deaths every year. Vaccines are crucial to prevent or treat cancers, viral, and bacterial infections, and serve as a rapid response to Infectious disease pandemics like Ebola, MERS, and most recently, COVID-19.

To help sponsors develop best-in-class vaccines that improve the length or quality of patient's lives, Veristat has assembled an extraordinary team of bold-thinking experts to design, build, and run your clinical program. Having planned and executed over 170+ vaccine projects and 5 vaccine Biologics License Applications (BLAs) our teams can strategically advance your vaccine through regulatory hurdles, recruitment challenges, and the approval process to safely bring vaccines to market.

Overcoming Key Challenges in Vaccine Development

We understand that vaccine development has a unique set of challenges from clinical studies to regulatory approval to post-market monitoring – all of which require integrated expertise for successful execution.

Whether you are developing 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, and the newest DNA vaccines.

Veristat’s experienced teams are poised to rapidly design and run your vaccine trials.

How We Help:

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.

Study Collaboration for a Successful COVID-19 Vaccine Program

Learn how Veristat supported HIPRA, a European multinational pharmaceutical company, with a full range of clinical trial services that culminated in EMA approval for HIPRA’s BIMERVAX^® COVID-19 vaccine. Having specialized in veterinary vaccines over its 50 years, HIPRA relied on Veristat’s extensive human vaccine experience to help the company swiftly progress through its clinical trials.

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Whatever the study’s unique considerations, our highly qualified team of regulatory and clinical development experts provide creative, strategic, and agile approaches to tackle the most complex challenges in program design, clinical trial conduct, and the regulatory approval process. If you’re looking for full-service solutions, support for a single service, or need specific experts to augment your in-house resources, Veristat can help. Contact Us.