Our expert team of industry-leading Physician/Principal Investigators (PIs) closely collaborates with pharmaceutical companies from pre-study protocol design through successful trial execution.
Our staff has extensive experience with First-in-Human (FIH), Phase I vaccine trial conduct all the way through to Phase III pivotal trials and subsequent regulatory approval. This has resulted in the successful execution of over 200 vaccine trials in a broad array of infectious and biodefense indications; including seasonal and pandemic influenza, ZIKA, Ebola, HIV, Cholera, Smallpox, Meningococcal Group B, Staphylococcus-aureus, C. difficile, Typhoid, Botulism, Anthrax, Rabies, West Nile Virus, RSV, Noro Virus, HPV, HSV-2, and many others.
Our site has unique capabilities for real-time PBMC isolation, which allows for efficacy evaluation of cell mediated immunity. There is high demand and need for this critical service in the vaccine industry and only a few clinical sites have this specialized capability. Our PBMC lab is certified through the Duke University Proficiency Program to ensure the highest quality is met and maintained. Our highly trained staff has experience with the Institutional Biosafety Committee (IBC) for safe handling of potentially harmful vaccine products (e.g. Ebola, HIV, and Cholera vaccines).
- Pediatric, adult, and elderly vaccine clinical trial experience
- Subject retention averages over 95%
- On-site PBMC laboratory
- Proud recipient of Best Clinical Trial Site and/or Network World Vaccine Congress 2018