For more than 10 years, the FHI Clinical project team has partnered with companies developing and deploying vaccines, treatments and preventive devices for malaria in 35 countries worldwide.
FHI Clinical has long-standing relationships, a local team and broad expertise in sub-Saharan Africa. We're ready to help you confidently expand your research across the region, finding the best-fit countries and populations for your target indication and study type.
Our site managers partner with study sites to ensure their success throughout the length of the project. This can include training and re-training for procedures, processes, protocol, ICH GCP, data management, informed consent and more.
The study team maintained a 91% retention rate in a study of a Chikungunya virus (CHIKV) vaccine, despite study disruptions due to natural disasters, including Hurricane Maria, and political unrest near the sites in five Caribbean countries in a CHIKV endemic region.
The FHI Clinical project team supported site monitoring, site management and project management to assist the University of Notre Dame investigators achieve a level of rigor not typically required for a non-medical product in their double-blinded, randomized-cluster, placebo-controlled clinical trial of a spatial repellent against mosquitoes for malaria prevention.
Since 1976, Ebola virus disease outbreaks have primarily occurred in eleven countries: Democratic Republic of the Congo, Gabon, Guinea, Liberia, Mali, Nigeria, Republic of Congo, Sierra Leone, Sudan and Uganda. Although it is generally rare, it is often fatal, with death rates ranging from 25 to 90% in past outbreaks (average case fatality rate, 50%). No treatment or vaccine is currently approved, but there are several promising vaccines and treatments under development.
Data monitoring strategies implemented by our bilingual CRA helped eliminate the backlog to ensure timely database lock in a phase 2 trial for Sanaria's innovative PfSPZ Vaccine for malaria in Equatorial Guinea, an area with limited prior research experience.
In a study conducted at 17 sites spanning nine countries in a Zika endemic region of the Americas and Caribbean, timely staffing of contract research associates (CRAs) was enabled by the project team’s network of bilingual resources and knowledge of local hiring practices.
CHIKV outbreaks have occurred in countries in Africa, Asia, Europe, and the Indian and Pacific Oceans. It was found for the first time in the Americas on islands in the Caribbean in 2013 and has spread throughout most of the Americas. It has since been identified in over 60 countries in Asia, Africa, Europe and the Americas. No commercially available vaccine to prevent or medicine to treat CHIKV infection is currently available.
Within a challenging, resource-limited setting, the project team succeeded in reaching FP/FV six weeks after arrival in Sierra Leone and 99.998% accuracy of the planned-to-execute budget.