Site Selection and Assessment
Our multifaceted approach to site identification and selection is tailored to each study protocol to ensure the best-fit sites with the most appropriate capabilities and population.
investing in research-ready sites
Our relationships with sites are built on our shared investment in their sustainability, helping sites develop and maintain research capacity so they are research-ready as soon as there is a need. Ultimately, this increased research capacity will help address public health issues around the globe.
Benefits of Collaboration
scalable, global site selection
Using a combination of our established relationships and analytics on our extensive database of high-quality, research-ready sites, the FHI Clinical team helps select the sites that are the best fit for your protocol(s).
Established Relationships
We rely on our established network of ~2,800 sites in nearly 75 countries worldwide that have the required infrastructure and community engagement capabilities to help locate, recruit and retain patients for observational and epidemiological studies and across all clinical trial phases, from Phase 1 to Phase 4.
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Our Involvement in Research Networks
Top 9 Indications Supported by Our Database of Sites
- Chikungunya
- COVID-19
- Dengue fever
- Diabetes
- HIV
- Hypertension
- Influenza
- Malaria
- Tuberculosis
Of the sites in our database:
~
0
%
of sites have 6+ years of experience
~
0
%
of sites have vaccine clinical trial experience
~
0
%
of those sites have 7+ years of vaccine clinical trial experience
Competitive Intelligence and Analytics
Using our proprietary database of thousands of established, high-quality sites, our Global Strategy team analyzes their capabilities and populations served against your protocol requirements. This feasibility assessment continues throughout the study to ensure successful performance.
comprehensive, customized site assessment
Site feasibility assessments ensure that the “ideal sites” are identified for a specific protocol. To achieve this, we’ve developed assessment strategies and tools based on industry best practices, input from our team of Scientific Advisory Experts and our experience with sites that successfully contribute to studies.
Our site feasibility assessments incorporate the following:
- Interviews with field staff
- Population demographics
- Local disease incidence data
- Survey question design and overall strategy
- Local and national regulatory and ethics processes
- Surrounding political environment
- Number and availability of staff
- Investigator and staff experience in clinical trials and the disease/condition of interest
- GCP training status
- Level of community engagement
- Evaluation of laboratory capacity and experience with the disease/condition of interest
- Specimen collection, processing and storage capabilities
- Pharmacy and pharmacist capabilities
- Facility equipment, maintenance and back-up
- Process of onboarding sites
PROVEN ABILITY FOR RAPID SITE SELECTION AND ASSESSMENT
Based on our experience in crisis-response settings, we’ve developed a key set of activities and resources that enable us to meet compressed trial start-up timelines.
Learn more about our specific experience through our case studies:
Case Study
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
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
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.
