Leverage Our Full-Service Solutions

Access best-in-class, end-to-end solutions for your global research needs.

we are your study partner

Take advantage of our years of experience and unique global network to comprehensively support your portfolio strategy, determine feasibility and rapidly develop sites in research-naïve areas.

BUILDING & SUSTAINING RESEARCH CAPACITY

We believe that building and sustaining research capacity, particularly in resource-limited, research-naïve areas, will help address public health issues around the globe.

Use our services to conduct your entire study or fill the gaps in your capabilities.

Tailor our services to meet your needs, from protocol design and site assessment to trial planning, implementation and management.

We are Responsive, Agile and Exact

We go beyond formulaic approaches because a one-size-fits-all approach to implementing clinical trials is inefficient and ineffective.

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Inexperienced sites require additional support. Inadequate infrastructure benefits from creative solutions. In areas of conflict, a Plan B, and sometimes a Plan C, is needed. Therefore, our approach is designed to:

Go beyond the typical sites to access the right populations.

We conduct high-quality studies in challenging locations characterized by limited research/healthcare infrastructure, ongoing conflict and decentralized patient populations.

We address challenges across dozens of therapeutic areas, including infectious diseases (IDs), neglected tropical diseases (NTDs) and emerging/reemerging diseases.

We facilitate sustainable research capacity through training and by pairing sponsors with research-ready sites that have access to the right patient populations.

WE HAVE PROVEN RESULTS

Rapidly and efficiently implement solutions for the most challenging problems in your studies by leveraging our experience in some of the most complex situations around the world.

0
weeks after arrival

first patient first visit (FPFV) in an Ebola outbreak setting in a country with no previous clinical research experience and limited infrastructure

60 %
retention rate

in an oncology study challenged by poor patient enrollment and retention due to a lengthy follow-up period

81 %
retention rate

in a Chikungunya study conducted in countries in the Caribbean disrupted by political unrest and natural disasters

"The FHI Clinical project management team has provided clear and informative guidance on expected processes and standards for rigorous clinical trial oversight...and has been a good partner in our spatial repellent studies."
Nicole L. Achee, PhD
Eck Institute for Global Health, University of Notre Dame

Learn more about our specific experience through our case studies:

Case Study
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Phase II Trial of a Chikungunya Vaccine in the Caribbean

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.
Case Study
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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.
Case Study
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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.
Case Study
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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.
Case Study
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Phase II/IIb Trial of a Zika Vaccine Spanning Nine Countries

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.
Case Study
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Clinical Research Training to Support Capacity Building in Liberia

To equip Liberia with the ability to respond to ongoing health issues and potential outbreaks, a US government contract provided funding to train local leaders in Liberia’s clinical research infrastructure network. The training aimed to build a solid foundation to conduct international quality clinical research.
Case Study
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Building Capacity for Tuberculosis Research in China: The China TB Clinical Trials Consortium (CTCTC)

To help address the high global TB incidence and related death rate, the China TB Clinical Trials Consortium (CTCTC) was established by government and industry partners to help build clinical research capacity in China, which has a particularly high tuberculosis incidence.
Case Study
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Rapid Study Start-Up for the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)

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.
Case Study
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Rescue of an Ongoing Global, Multi-Site Oncology Trial

In a Phase 3 study with a lengthy intervention for colorectal cancer, the project team reached a 70% retention rate, with steadily increasing enrollment rates, by implementing strategies to address poor patient enrollment and retention.