Infectious Disease Clinical Development Expertise

Getting a novel infectious disease vaccine or treatment on the market today is extremely critical and complex.

Infectious diseases are a threat to global health and way of life everywhere – particularly in the midst of the current COVID-19 pandemic. Time is of the essence when it comes to developing safe and effective infectious disease vaccines and treatments. In addition to recent pandemic outbreaks caused by viral infections, more treatment-resistant bacterial and fungal infections are rising, with antibiotics and antifungals becoming less effective.

Our scientific-minded infectious disease experts can help navigate this challenging landscape, having conducted more than 300 projects for Infectious Disease treatments and vaccines.

Experience Battling Infectious Diseases

Whether you are aiming to prevent or combat a viral, bacterial, fungal or parasitic infection, Veristat can help make the difference for your study’s success. Our teams understand the nuances and difficulties involved with treating infectious diseases, have the experience to perform vaccine trials, and are adept with rapid response to global pandemics that arise, such as the current COVID-19 outbreak response.

At Veristat, our experienced teams are poised to plan and implement these efforts quickly providing:

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.

Recent Pandemic Experience
	> 250 Projects for infectious disease treatments and vaccines

	50+ COVID-19 vaccines/therapeutics

	50+ Influenza vaccine programs

	8 Ebola vaccine projects for 2014 outbreak

Prevention and Treatment of Bacterial & Fungal Infections
Acinetobacter Baumannii Infections	Gram-Negative Infections
Acute Bacterial Skin and Skin Structure Infections (ABSSI)	H. Pylori Infection
Bacterial Pneumonia	Joint infection
Botulinum vaccine	Methicillin-resistant Staphylococcus aureus (MRSA) Bacteremia
Candidemia	Nasal Infection
Clostridium Difficile (C.Diff)	Nontuberculous Mycobacterial (NTM) Lung Disease
Complicated Intra-Abdominal Infections (cIAI)	Nosocomial Infection
Complicated Skin and Skin Structure Infection (CSSSI)	Onychomycosis
Complicated Urinary Tract Infection including Pyelonephritis	Staphylococcus Aureus
Cystic Fibrosis-Pseudomonas	Surgical Site Infections
Endocarditis	Vacomycin-Resistant Enterococcal Infections

Prevention and Treatment of Viruses/Viral Infection
COVID 19	Influenza - Pandemic
Cytomegalovirus (CMV) Infection	Lassa Fever
Ebola	Malaria
Epstein Barr Virus (EBV)	Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Hepatitis A, B & C	Recurrent Respiratory Papillomatosis (RRP)
Herpes (HSV2)	Respiratory Syncytial Virus
HIV / AIDS	RNA Vaccine Platforms for multiple types of Infectious Diseases/Cancers
Human Papilloma Virus (HPV)	Shingles - Varicella-Zoster Virus (VZV)
Influenza - H1N1	Smallpox
Influenza - H5N1	Sexually Transmitted Infections
Influenza - Seasonal	Typhoid Fever
Influenza (Universal Vaccine)	West Nile Virus

Learn More with These Resources

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Marketing Applications Approval Record

Veristat is proud to have supported the preparation of 75 marketing applications (NDA, BLA, MAA, etc) that are now approved for patients. For these approved products, ...