Our Research Services | FHI Clinical

Our Services

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:

To learn more, 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:

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

years (avg)

Our staff have an average of 16 years of experience in project management

0 +

countries

Our project management experience spans 55+ countries around the globe

0 +

therapeutic areas

We have provided project management for studies covering 14+ 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:

A customized training program based on educational background and previous clinical monitoring experience

A minimum of three monitoring visits accompanied by an experienced CRA

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

years (avg)

Staff are seasoned data managers, trainers and programmers with an average 14 years of experience in clinical trial data management and application development

We use a combination of different software for data management:

OpenClinica: used as the primary clinical data management (CDM) platform

RedCap: used for survey research

DM Net: internally developed, web-based reporting and pharmacovigilance system

OUr biostatistics services include:

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:

We have supported laboratories across the globe.

0 +

Conducted more than 500 Good Clinical Laboratory Practice (GCLP) audits

0 +

Provided training to more than 1,500 laboratory technicians across Africa, Asia and Latin America

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

"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

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.

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.