Clinical trials design and implementation

FHI 360 conducts and supports clinical research in resource-limited settings around the world. We bring technical, regulatory and cultural expertise to regions where the need and opportunity for clinical research are greatest. We work with governments, ministries of health and local partners to build capacity, strengthen research services, test products and improve lives.

In collaboration with global networks and partner organizations, FHI 360 designs, implements, manages and monitors complex studies, including multisite and multicountry clinical trials. We also bring expertise on the important behavioral aspects of clinical trial design, conduct and measures. FHI 360 offers a full range of clinical research services that ensure efficient, cost-effective trials with reliable results. We assist with:

Study design
Site identification and development
Site monitoring, management and training
Data management, quality and integrity
Biostatistics and statistical analysis
Protocol development
Protection of participants’ safety and rights
Research ethics training
Community preparedness for clinical trials
Research operations
Logistical support

Full-service clinical research organization

In addition to our work with governments and foundations, FHI 360 acts as a full-service clinical research organization (CRO) to the pharmaceutical industry, setting up and managing studies for them in the Americas, Asia Pacific and Africa.

Our global team of clinical research specialists includes:

Clinical project managers
Clinical research associates
Regulatory affairs and quality assurance specialists
Laboratory technologists
Epidemiologists
Document specialists
Biostatisticians
Data management specialists
Medical writers

You can learn more by viewing FHI 360's fact sheet on global research and services.

Science facilitation and research networks

FHI 360 serves as the coordinating and operating center for clinical research networks in Asia, Africa, Latin America and the United States. These networks use their collective experience to:

Foster innovation within the network
Develop study concepts and protocols
Engage stakeholders in activities of clinical trial networks
Increase local capacity in conducting clinical trials
Work with investigators to disseminate information about clinical trials and results

Clinical trials

We support every aspect of Phase I to Phase IV clinical trials. FHI 360 scientists have evaluated nearly every type of modern contraceptive method tested in the past 40 years. And, our trials were among the first to demonstrate that antiretroviral therapy (ART) for HIV-positive patients can be scaled up in resource-limited settings.

FHI 360 experts have designed and conducted clinical trials in:

HIV/AIDS and other sexually transmitted infections
Contraceptive methods
Malaria
Dengue fever
Tuberculosis
Influenza
Rotavirus
Human papillomavirus
Reproductive health

Examples of recent clinical trials include those to assess:

The effects of a daily oral antiretroviral (Truvada) for HIV prevention
The use of the ShangRing for voluntary medical male circumcision
The use of a generic contraceptive implant
Treatments for latent and active tuberculosis

Complementary studies

FHI 360’s behavioral and social scientists go beyond clinical sciences to conduct complementary studies related to issues such as:

Community acceptance of novel interventions
Patterns of medication or device use
Adherence to recommended prevention guidelines
Risk taking as it relates to HIV/AIDS and other infectious diseases

Published research

Our scientists publish more than 100 articles each year in peer-reviewed journals, facilitating research utilization to improve lives.

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Clinical trials design and implementation