Full-Service Global Support for COVID-19 StudiesFHI Clinical addresses emerging pandemics, epidemics and outbreaks

with expertise that supports health and research efforts globally.

We are experienced in addressing the complex aspects of infectious

diseases — from infection prevention and control to clinical research

on diagnostics, vaccines and treatment.

We remain prepared to launch studies in response to the most

challenging of situations. Because it is not if, but when, an emergency

response will be required, the standard operating procedures (SOPs)

and processes that we have developed and refined during our years

of outbreak experience are up-to-date and ready to deploy when

needed.

FHICLINICAL.COM

FHI Clinical is currently supporting multiple SARS-CoV-2 studies:

• Phase I/II treatment clinical trial

• Phase II treatment clinical trial

• Phase III treatment clinical trials

• Observational study

Data current as of October 1, 2020

RAPID STUDY START-UPOur team is experienced at rapid start-up and management of complex clinical research

at clinical sites diverse in geographic area and research capacity. Our broad expertise and

ability to begin immediate collaboration with government, commercial and academic

partners in more than 60 countries globally — combined with the FHI 360 family of

companies — make FHI Clinical uniquely positioned to support the COVID-19 response.

FHI Clinical’s Rapid Start-Up Process was honed during the 2014–2016 West Africa Ebola

outbreak. Our project staff arrived in Sierra Leone within 10 days of project start, and within

three weeks, the team trained more than 300 newly hired site staff. FHI Clinical has the

experience to rapidly initiate large multicenter research projects, yet we are agile enough

to fill gaps and respond to urgent needs, working within parameters required to maintain

sound management structures.

We follow a core set of steps to achieve rapid study start-up

INITIATEInitiate pre-award operations with staff from multiple departments

CLARIFYClarify roles and responsibilities of all personnel

PRIORITIZEPrioritize critical start-up activities and the corresponding staff

DEPLOYDeploy technical teammates and hire in-country staff

CONDUCTConduct in-country launch meeting with key staff

50+countries around

the globe

• Acute febrile illness

• Chikungunya*

• COVID-19*

• Dengue

• Ebola virus disease*

• Gastroenteritis

• Genital herpes

• HIV

• Influenza (including H1N1*, H5N1*)

Our involvement with infectious diseases includes clinical trials and observational studies

across 50+ countries for vaccines, therapeutics, vector control and behavioral interventions

for the following diseases:

• Japanese encephalitis

• Lymphatic filiarisis

• Malaria

• Nipah virus

• Onchocerciasis

• Pneumonia

• Syphilis

• Tuberculosis

• Zika virus disease*

*involvement includes during outbreaks

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OUR INFECTIOUS DISEASE EXPERIENCE

start-up times possible with FHI Clinical

involvement

6-8 week

Protocol developmentOur network of infectious disease medical experts reviews and provides

input on protocol strategy, including the best population to study and the

feasibility of endpoints and biomarkers. Our biostatisticians also contribute

to a thorough review of the study protocol as well as relevant content for

specific protocol sections.

Regulatory assistanceFHI Clinical has established relationships with regulatory agencies in

numerous countries in North America, the Caribbean, South America, Africa,

Asia, the Middle East and Europe. We are adept at managing the nuances

of local regulatory requirements in multi-country studies, including specific

requirements for product labeling, drug shipment authorization, protocol,

trial master files and other essential documents.

Global site selection and patient recruitment strategySite selection is a critical first step to rapid, effective patient recruitment

and engagement. We conduct site feasibility assessments based on

epidemiological data, facility capabilities around physical infrastructure

and clinical staff, ability of the site to accept/allow a central institutional

review board review, and approval and support for expedited contract/

budget execution.

Project managementOur project management experience spans our history of infectious disease

work, including outbreaks for Ebola, chikungunya, Zika, avian influenza and

more. In addition to traditional project management services, we contribute

our experience to:

16staff experience in infectious disease project management

We excel at challenging

trials of infectious

disease vaccines and

therapies that require

thorough planning and

contingency planning.

“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

We rely on our established

network of sites in countries

worldwide. Because we have

worked with these sites previously,

we know they have the required

infrastructure and community

engagement capabilities to help

locate, recruit and retain patients.

• Developing site plans based on prior site assessments

• Mentoring to build the capacity of site staff

• Defining situationally and locally relevant study risks and identifying critical risk indicators

• Implementing platforms for strict financial scrutiny and diverse systems and local requirements

Clinical operationsWe adapt our long-established model of training and mentoring of clinical

sites and laboratories to fill clinical research knowledge gaps at low-

performing sites to ensure that the trial is not compromised by the high

volume and geographic diversity of sites.

years (avg)

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CONTACT US:+1.919.321.3321info@fhiclinical.comfhiclinical.com

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Leverage our high-quality, end-to-end clinical trial services in this rapidly evolving public health

crisis. Visit fhiclinical.com, email us at info@fhiclinical.com or call 919.321.3321.

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• Assessment of site staff’s data management readiness

• SOP and clinical quality management plan (CQMP) development

• Remote data monitoring, when needed

BiostatisticsOur team of biostatisticians and statisticians, who have a median 19 years of

statistical analysis experience, supports the early development of statistical

analysis plans (SAPs) and maintenance of a validated, flexible, customizable

randomization system.

Medical affairs and safety servicesOur global network of medical affairs and safety experts provides oversight

of safety signals according to the protocol. They also provide input regarding

ongoing pharmacovigilance to ensure product safety.

Data managementThe FHI Clinical team has 25 years of experience providing high-quality,

customized global data management solutions for studies throughout Asia,

Africa and the Americas. Our services include:

5

6

full-time, PhD-level biostatisticians

Master’s-level statisticians

years25data management experience