Solutions

Agile Vaccine Clinical Development Expertise

Accelerating vaccine development to prevent and treat virulent diseases

Vaccine developers worldwide are faced with the challenge of quickly and safely advancing their vaccines through the clinical development and approval process to prevent millions of deaths every year. Infectious disease pandemics like Ebola, MERS, and COVID-19 come to mind currently, requiring a rapid response to regional or global outbreaks.

Equally important are vaccines to prevent or treat cancers, viral, and bacterial infections that impact the length or quality of human lives.

At Veristat, we have the scientific-minded experts ready to advance your vaccine through the regulatory hurdles, recruitment challenges, and approval process to safely bring vaccines to market, having supported 160+ vaccine projects to date.

Understanding Vaccine Trials

We understand that vaccine development has a unique set of challenges, so Veristat has assembled an extraordinary team of scientific-minded experts who have planned and executed over 160 vaccine projects and supported numerous marketing applications.

Whether 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, or even the newest DNA vaccines.

At Veristat, our 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.

Knowledge From a Broad Range of Vaccine Experience
Botulinum Vaccine	Lymphoma
Breast Cancer	Melanoma
C Difficile	Metastatic Breast Cancer
Cervical Cancer	Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Colorectal Cancer	Non-Small Cell Lung Cancer
COVID-19	Pancreatic Cancer
Ebola	Pandemic Flu
Gastric Cancer	Prostate Cancer
Glioblastoma	Renal Cell Cancer
Head and Neck Squamous Cell Carcinoma (HNSCC)	Respiratory Syncytial Virus
Hepatitis A	Shingles -Varicella-Zoster Virus (VZV)
Hepatitis B	Smallpox
Herpes (HSV2)	Thyroid Cancer
Human Papilloma Virus (HPV)	Typhoid Fever
Influenza	Vulva Cancer
Liver Metastasis	Yellow Fever