Solutions

Vaccine Development CRO and Regulatory Partner

Accelerate your vaccine development with scientific clinical development expertise

Vaccine developers worldwide face 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 rapidly respond 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 patients' lives, Veristat has assembled an extraordinary team of scientific experts to design, build, and run your clinical program. Having planned and executed over 175+ vaccine clinical trials and consulting projects, including the preparation of 5 vaccine Biologics License Applications (BLAs) our teams can strategically advance your vaccine through regulatory hurdles, recruitment challenges, and the approval process to bring vaccines to market safely.

Developing a Vaccine? Let's Talk.

Overcome Key Vaccine Clinical Development Challenges

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, such as the recent 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 design and run your vaccine trials rapidly.

Scientific Experts Bring Your Vaccines to Market Rapidly with:

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.

Covid-19 Hipra Vaccine Development

Infectious Disease Vaccines

Coronaviruses (SARs CoV1, SARs CoV2, and MERS-CoV)
Ebola
Human Papilloma Virus (HPV)
Influenza- Seasonal & Pandemic
Respiratory Syncytial Virus (RSV)
Smallpox
Varicella-Zoster Virus (VZV)
and more...

Cancer Vaccines

Breast Cancer
Head & Neck Cancer
Lymphoma
Melanoma
Ovarian Cancer
Pancreatic Cancer
and more...

Advance Your Vaccine Trial with Confidence

Whatever your challenges are, our highly qualified 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 clinical trial solutions, support for a single service, regulatory or strategic advice, or need specific experts to augment your in-house resources, Veristat can help.