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.
Vaccine Development Experience in the Past 5 Years
Vaccine trials and consulting projects
Infectious Disease Vaccines
of Veristat clinical trial teams have supported vaccines
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.
Type of Vaccines Supported By Veristat
Infectious Disease Vaccines
- Coronaviruses (SARs CoV1, SARs CoV2, and MERS-CoV)
Human Papilloma Virus (HPV)
Influenza- Seasonal & Pandemic
Respiratory Syncytial Virus (RSV)
Varicella-Zoster Virus (VZV)
- Breast Cancer
- Head & Neck Cancer
- 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.
More than 70% of our scientific clinical trial experts have supported vaccine trials. Contact Us.
"We thank the entire Veristat team, who has worked so diligently. We are gratified to know that the efforts and commitment of Verisat has resulted in an approved vaccine to advance protection against the virus.”