Our capabilities and experience

Read more about how we help manage complex clinical research across many therapeutic areas worldwide.

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Case Study

Site Monitoring & Management in a Clinical Trial of a Spatial Repellent for Vector-Borne Disease Control

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.


Indication Overview

Our Clinical Trial Experience With Ebola Virus Disease

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.


Webinar

Successful Outbreak Responses Depend On Reliable Data

In this webinar, industry veterans Michelle Berrey, MD, MPH, and Claudia Christian discuss the importance of  quality data for a successful outbreak response plan.


Indication Overview

Dengue Fever Fact Sheet

Dengue fever, a mosquito-borne tropical disease, is the most common and important arthropod-borne (arboviral) illness in humans. It is caused by four serotypes of the dengue virus, of which more than one can circulate during an epidemic. Infection with one serotype confers lifelong homotypic immunity to that serotype and a brief period (~2 years) of partial heterotypic immunity to other serotypes. However, an individual can eventually be infected by all four serotypes.


Infographic

8 Key Lessons for Outbreak Responses

Outbreaks large and small require rapid, coordinated responses. In this infographic, we describe eight considerations for outbreak responses, based on the collective experience of our experts.


Case Study

Rapid Site Assessment and Recommendations for Clinical Trials of a New Malaria Treatment

Targeted geographic areas for the development of an antimalarial drug by Novartis included malaria-endemic regions in Africa and Asia, and Novartis requested assistance identifying and assessing potential clinical sites for their planned clinical trial. Our team conducted 38 rapid, in-depth, 2.5-day site feasibility assessments in the 18 countries.


e-Book

What Can We Learn From Past Outbreaks?

Outbreaks large and small require rapid, coordinated responses. In this e-book, we describe eight considerations for outbreak responses, based on the collective experience of our experts.


Indication Overview

Schistosomiasis Fact Sheet

Also known as snail fever, schistosomiasis is caused by parasitic flatworms called schistosomes. It is spread through contact with contaminated fresh water. Most human cases are caused by specific species of flatworms. In tropical countries, it is second only to malaria among parasitic diseases with the greatest economic impact. Schistosomiasis affects almost 200 million individuals per year, with most cases occurring in Africa, Asia and South America.


Indication Overview

Lassa Fever Fact Sheet

Lassa fever is a type of hemorrhagic fever caused by the Lassa virus and is mainly transmitted by rodents. The virus was first detected in 1969 in the town of Lassa, in Borno State, Nigeria; hence, its name. Lassa is endemic to West Africa, specifically Nigeria, Liberia, Sierra Leone and Guinea. A significant number of individuals infected by the Lassa virus (~80%) do not appear to develop symptoms. The case fatality rate (CFR) has been reported to be upwards of 70%


Case Study

Providing Site Monitoring and Management Expertise in Malaria Vaccine Trials in Equatorial Guinea

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.