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Extending our scientific depth across allergy, dermatology, ophthalmology, respiratory, women's health, and more.

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Vaccines

Vaccine programs move on tight timelines, and your plan needs to keep up

Regulatory paths, recruitment, and fast-moving pathogens can slow a program down. Our scientists help you see the risks early and keep your vaccine moving toward approval.

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Vaccine Development CRO and Regulatory Partner

Accelerate your vaccine development with scientific clinical development expertise

Vaccine developers worldwide face a complex challenge: advancing their vaccines safely and quickly 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 and 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 more than 55 vaccine clinical trials and consulting projects in the past 5 years, our teams navigate regulatory complexities, overcome recruitment challenges, and streamline the approval process to bring safe, effective vaccines to market.

 

55+

vaccine trials and consulting projects in the past 5 years

Types of Vaccines Supported by Veristat

From infectious disease outbreaks to oncology, our team brings hands-on clinical development experience across the vaccine landscape. Here's where that experience runs deepest.

Infectious Disease Vaccines

Whether responding to an emerging pathogen or advancing a well-established target, we've supported vaccine programs across a range of infectious diseases, including:

  • Coronaviruses (SARS-CoV-1, SARS-CoV-2, and MERS-CoV)
  • Ebola
  • Herpes Simplex Virus (HSV)
  • Influenza — Seasonal & Pandemic
  • Respiratory Syncytial Virus (RSV)
  • Varicella-Zoster Virus (VZV)
Cancer Vaccines

Our team also brings experience to vaccines designed to prevent or treat cancer, spanning a range of tumor types, including:

  • Breast Cancer
  • Head & Neck Cancer
  • Melanoma
  • Ovarian Cancer
  • Renal Cancer
  • Solid Tumors — AI powered
Why Veristat 

Our scientific experts bring your vaccine to market rapidly with:

No matter what stands in your way, 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.

Regulatory Strategy

Development of regulatory strategy, expedited pathways, and regulatory agency interactions.

Clinical Program Planning

Statistical planning and analysis built into every program design.

 

Patient Recruitment

Agile strategies that support virtual trial and hybrid approaches.

Clinical Trial Databases

Rapid deployment to keep your program moving.

Site Monitoring

Virtual and remote clinical and medical site monitoring.

Data Management

Data analysis and migration into CDISC formats.

Regulatory and Safety Writing

Clinical trial, safety, and regulatory documentation.

Marketing Applications

Preparation and defense of NDAs, BLAs, NDSs, MAAs, jNDAs, and more.

quote

“We thank the entire Veristat team, who has worked so diligently. We are gratified to know that the efforts and commitment of Veristat has resulted in an approved vaccine to advance protection against the virus.”

— Spanish Pharmaceutical Company

PROOF POINTS

What our vaccine experience looks like in numbers

55+

vaccine trials and consulting projects.

70%+

of Veristat clinical trial teams have supported vaccine trials

PROOF & RESOURCES

Real Programs, Real Outcomes

infographic
 
A Practical Guide for Managing Multiple Global Regulatory Pathways

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infographic
 
FDA Expedited Programs – What You Need to Know

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Fact sheet
 
Side-by-Side Comparison: Non-Adaptive vs. Adaptive Designs in ...

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Tell us where your vaccine program stands

Whether you're developing a vaccine to treat cancer or respond to an infectious disease outbreak like COVID-19, we tackle the complexities of testing immunotherapy, viral, and DNA vaccines. We've assembled a team of scientific experts who understand the unknowns of vaccine development, helping sponsors succeed in extending and saving lives.

 

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