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.
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.
Cancer vaccine projects supported
Vaccines for rare diseases
Supporting Cancer and Infectious Agent Vaccines
Knowledge From a Broad Range of Vaccine Experience
|C Difficile||Metastatic Breast Cancer|
|Cervical Cancer||Middle East Respiratory Syndrome Coronavirus (MERS-CoV)|
|Colorectal Cancer||Non-Small Cell Lung Cancer|
|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)|
|Herpes (HSV2)||Thyroid Cancer|
|Human Papilloma Virus (HPV)||Typhoid Fever|
|Liver Metastasis||Yellow Fever|