Infectious Diseases & Vaccines
Accelerating development in infectious disease and vaccine clinical trials
Infectious disease and vaccine research is unique in its ability to have widespread impact on public health. At Syneos Health®, each and every one of us on our Infectious Disease team is devoted to advancing this important work.
True therapeutic alignment gives us not only an unparalleled depth and breadth of expertise among our best-in-class infectious disease study teams, but also deep partnerships with known and trusted sites and investigators across the globe – relationships that are always important but are especially critical when time is of the essence during fast-moving outbreaks.
Industry-leading experience as an infectious disease CRO
- A broad range of infectious disease and vaccine clinical research consulting expertise in bacteriology, virology, mycology, and associated diseases and syndromes
- Work in both preventative and therapeutic vaccines, including for common diseases like influenza, respiratory syncytial virus and S. pneumoniae, as well as emerging threats like Ebola virus, Zika virus and COVID-19 (coronavirus)
- A proven record of success in all forms of regulated anti-infective and immunologic agents, including drugs, biologics and devices
- A comprehensive set of services covering Phase I-IV infectious disease clinical trials at a global level, including full Phase I study capabilities for first-in-human and immunogenicity studies, in a wide range of patient populations
- Regulatory engagement for planning and study start-up worldwide, supported by dedicated regulatory intelligence and country-specific regulatory specialists
- Expertise navigating the nuanced requirements and aggressive timelines set forth by government agencies
Partnering to address the threat posed by COVID-19 and other emerging infectious diseases
- Extensive organizational and individual experience in emerging infections, public health emergencies and biomedical counter-measures, including complex studies for Zika and Ebola viruses and other emerging health threats
- Access to our Vaccine Catalyst Site Network, consisting of more than 30 high-performing sites focused on vaccine research and aligned with our processes to deliver rapid trial start-up and execution and yield high-quality subject data
Site relationships that are second to none
- Strong, long-term relationships with sites enabling rapid start-up, predictability and orchestration of complex logistical requirements
- Staff or capabilities in countries throughout Asia, Europe, Africa, Australia and the Americas for all elements of clinical research
Our work includes projects targeting:
- Complex hospitalized infections targeting gram-negative pathogens (e.g., complicated urinary tract infections, healthcare and ventilator-associated pneumonias)
- Predominantly gram-positive infections (e.g., bacteremia and endocarditis, acute bacterial skin infections, osteomyelitis and C. difficile infections, both acute and recurrent with microbiome replacement)
- Invasive fungal infections (e.g., aspergillosis, candidemia)
- In addition, we have established pathways for HIV and hepatitis clinical development, and have conducted studies in challenging respiratory syncytial virus and other respiratory infections.
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