Our clinical experts in infectious disease and vaccine clinical trials offer a broad range of therapeutic expertise in bacteriology, virology, mycology, and associated diseases and syndromes. We have a proven record of success in all forms of regulated anti-infective and immunologic agents, including drugs, biologics and devices.
We have significant experience of all commonly studied populations, including pediatric, as well as populations with unique clinical issues, such as HIV infection, stem cell transplantation, chronic hepatitis, multidrug resistance, sepsis/septic shock, and trauma.
Our experience on behalf of various sponsors spans all phases of drug development, involves both adult and pediatric age groups, and encompasses a vast geographic area.
Our team leverages extensive experience to optimize efficiencies throughout your trial. Of particular advantage are excellent working relationships with sites, and the ability to carefully orchestrate complex logistical requirements to deliver patients, medication, and data in a timely manner and of the highest quality.
Our Work in Practice
We have conducted many projects related to complex hospitalized infections targeting gram-negative pathogens, and C. difficile infections, including acute and recurrent disease. We have delivered vaccine trials for Ebola virus, Zika virus and other emerging health threats.
We have tackled gram-positive infections in acute bacterial skin and skin structure, endocarditis and osteomyelitis, and established pathways for early phase development in hepatitis and challenging Respiratory Syncytial Virus.
Our Vaccine Program Services
Our vaccine program services include integrated summaries and Biologics License Applications (BLA) guidance in the pre-licensure stage; post-licensure surveillance capabilities such as Risk Evaluation and Mitigation Strategies (REMS), advisory committee support, drug safety management, epidemiology, and adjucation committees; and Health Economics and Outcomes Research (HEOR) and modeling support that ranges from reimbursement to Association of Clinical Research Professionals (ACRP) guidelines.