Our Full-Service Solutions
High-quality studies require proven, flexible services that support the entire research lifecycle
Access best-in-class, end-to-end solutions for your global research needs
USE our services to conduct your entire study or fill the gaps in your capabilities.
Leverage our expertise to address challenges across dozens of therapeutic areas, including infectious diseases, neglected tropical diseases and emerging and re-emerging diseases.
Our clinical trial solutions span the following:
Our site selection and assessment services include:
- Building and sustaining research capacity at sites
- Protocol feasibility assessments based on data mining and projections using our database of thousands of established, high-quality sites
- Rapid identification of study sites using our established relationships with and study database of clinical research sites worldwide
- Site feasibility assessments based on industry best practices, expert input and experience with successful sites
Learn more about our site selection and assessment services.
Read our case study describing how, in just two months, our team conducted 38 site feasibility assessments in 18 countries throughout Africa and Asia.
In addition, for a Chikungunya vaccine clinical trial in the Caribbean, our team accomplished the following in just two months:
- Identified 22 investigators and narrowed the total to 13
- Customized assessment tools and pre-assessment interviews
- Conducted 7 site evaluation visits, resulting in 6 sites selected
- Conducted pre-study site readiness assessments for pre-selected sites
Our site development, management and training services include:
- Identification of personnel who can be deployed from health response teams
- Full-time site support to assist research-naïve site staff
- Pre-deployment training for roles, study procedures and processes
- When possible, web-based re-training as issues arise
- Therapeutic and protocol-specific training for each study by in-house subject matter experts
- ICH GCP and protocol-specific training tailored to the sites’ needs
- Online and in-person data management training
- Informed consent training
Our project management services include:
- Site development plans based on prior site assessments
- Mentoring to build the capacity of site staff
- Clinical operations support
- Definition of study risks and identification of critical risk indicators, in collaboration with the sponsor
- Documentation of timelines and deliverables
- Implementation of financial platforms for strict financial scrutiny and to serve diverse systems and local requirements
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countries
therapeutic areas
Our clinical monitoring services include:
- Development of a study-specific monitoring plan in collaboration with the sponsor
- Customizing a recruitment and retention plan for each site
- Therapeutic and protocol-specific training for each study with continuous support by in-house subject matter experts
- Highly skilled field activities including assessment, initiation, interim monitoring and closeout visits
- Site management via a combination of on-site and remote monitoring to minimize risk and ensure compliance with ICH-GCP guidelines
All FHI Clinical's clinical research associates (CRAs) must complete:


Read our case study describing how the FHI Clinical project team supported site monitoring, site management and project management in a double-blinded, randomized-cluster, placebo-controlled clinical trial of a spatial repellent against mosquitoes for malaria prevention conducted by the University of Notre Dame.
Our data management services include:
- Full-service support to multi-country, multi-site clinical studies
- Assessment of site staff’s data management readiness
- Clinical operations support (e.g., standard operating procedure [SOP] and clinical quality management plan [CQMP] development)
- Provision of guidelines for handling data discrepancies
- Programming of automated alerts and data error checks in the database
years
Nearly 25 years of experience providing high-quality, customized global data management solutions for studies throughout Asia, Africa and South, Central and North America
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We use a combination of different software for data management:

OUr biostatistics services include:
- A thorough review of the study protocol
- Contribution to specific sections of the study protocol
- Early development of statistical analysis plans (SAPs)
- Maintenance of a validated, flexible, customizable randomization system
Our Biostatistics staff has the qualifications and experience to support your studies:
full-time, PhD-level biostatisticians
Masters-level statisticians
Bachelor’s-level statistician
median years of statistical analysis experience
Our laboratory support services include:
- Technical assistance, training, auditing and monitoring
- Examination of lab records, reports and source documents
- In-person interviews with staff
- Generation of the final report for the sponsor
We have supported laboratories across the globe.
Our regulatory services include:
- Registration of a study’s progress in clinicaltrials.gov
- Quality oversight and regulatory operations management
- Site support to meet local and central ethics/IRB requirements
- Support for regulatory strategy and operations
- Review of study product labeling, drug shipment authorization, protocol, trial master files and other essential documents


GLOBAL VACCINE DEVELOPMENT
To achieve our vision of a world where advances in vaccines help all people live longer, healthier lives, we’ve honed our processes to respond to the urgency and complexity of vaccine trials, developed our global network of investigators and sites, and partnered with organizations across public, private, academic and government sectors.
BUILDING AND 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.
OUTBREAK RESPONSE
At FHI Clinical, we use our past outbreak experience to lead responses in crisis situations—from rapid study start-up in research-naïve areas to leveraging existing research networks and contributing to local health systems.
RAPID STUDY START-UP
Based on our experience in crisis-response settings, we’ve developed a key set of activities and resources to meet compressed trial start-up timelines.
Site selection & 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.