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
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.
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
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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
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:
- Build site staff capacity by providing site-specific education and tailored training
- Ensure consistent, high-quality study data, regardless of the setting
- Consider the site’s resources when developing quality improvement strategies
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.
first patient first visit (FPFV) in an Ebola outbreak setting in a country with no previous clinical research experience and limited infrastructure
in an oncology study challenged by poor patient enrollment and retention due to a lengthy follow-up period
in a Chikungunya study conducted in countries in the Caribbean disrupted by political unrest and natural disasters
Learn more about our specific experience through our case studies:
Phase II Trial of a Chikungunya Vaccine in the Caribbean
Site Monitoring & Management in a Clinical Trial of a Spatial Repellent for Vector-Borne Disease Control
Rapid Site Assessment and Recommendations for Clinical Trials of a New Malaria Treatment
Providing Site Monitoring and Management Expertise in Malaria Vaccine Trials in Equatorial Guinea
Phase II/IIb Trial of a Zika Vaccine Spanning Nine Countries
Clinical Research Training to Support Capacity Building in Liberia
Building Capacity for Tuberculosis Research in China: The China TB Clinical Trials Consortium (CTCTC)
Rapid Study Start-Up for the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)
