Vaccine Development: Stay Two Steps Ahead with FHI ClinicalVaccines are critical to the eradication of infectious diseases

worldwide. To achieve the FHI Clinical vision of a world where

advances in vaccines help all people live longer, healthier lives,

we’ve spent years honing our processes to respond to the urgency

and complexity of vaccine trials, developing our global network of

research-ready investigators and sites, and partnering with leading

public and private medical research organizations, pharmaceutical

and biotechnology companies, academic institutions, governments

and non-governmental organizations.

As a result, we remain ready to deploy at a moment’s notice,

regardless of geography or therapeutic area.

FHICLINICAL.COM

FHI Clinical is currently supporting more than 10 vaccine studies for the following indications:

• Ebola virus disease

• Encephalitis

• HIV

• Human papillomavirus (HPV)

Data current as of October 1, 2021

• Malaria

• Nipah virus

• Pneumococcal disease

30countries around

the globe• Chikungunya

• Diphtheria/tetanus/pertussis

• Dengue

• Ebola virus disease

• Genital herpes

• HIV

• Human papillomavirus (HPV)

• Influenza

• Japanese encephalitis

• Malaria

• Nipah virus

• Pneumonia

• Rotavirus gastroenteritis

• Zika virus disease

OUR VACCINE TRIAL EXPERIENCEOur involvement with vaccines includes clinical trials sponsored by

commercial, non-profit, academic and government organizations

across 30 countries in Africa, Asia and the Americas for the

following diseases:

OVERCOMING CHALLENGES IN VACCINE TRIALSIn an NIAID-funded trial of a Chikungunya vaccine conducted in

the Dominican Republic, Guadeloupe, Haiti, Martinique and Puerto

Rico, Hurricane Maria resulted in lost power, internet, phone and

mail service in Puerto Rico, affecting follow-up visits, displacing

participants and challenging sample stability and logistics. Political

unrest in Haiti also displaced participants and sporadically forced clinic

closure. Site and study team collaborations ensured solutions were

appropriate for the context. Flexibility was crucial to address issues

and keep all stakeholders informed.

retention rate despite study disruptions due to natural disasters and political unrest

We excel at challenging

trials that require

thorough planning and

contingency planning.

91%

Polysaccharide conjugate

Inactivated

Live attenuated

VLP

DNA

Subunit

Vaccine Type

7%7%

11%

22%22%

30%

Clinical Phase

Phase

OtherIVIIIII/IIIIII/III

25%

20%

15%

10%

5%

0%

35%

30%

PHASE I PHASE II-III

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 — uniquely positions FHI Clinical to support vaccine trials.

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

1

2

3

4

5

start-up times possible with FHI Clinical

involvement

6-8week

SCALABLE, GLOBAL SITE SELECTIONWe rely on our established network of sites in countries worldwide that have the required infrastructure and

community engagement capabilities to help locate, recruit and retain patients across all clinical trial phases.

NetworksPhase I Phase II-III

We conduct data mining to match sites to the protocol.

We use proactive projections of enrollment per site to inform site selection.

END-TO-END CLINICAL TRIAL SOLUTIONSFrom the hard science to the human side of vaccine trials — we have the experience and expertise to review and advise

on protocols, identify qualified sites for each trial phase, engage the community for efficient enrollment and follow-up,

quickly establish and assess laboratories, rapidly deploy data management services and more.

359 Blackwell Street, Suite 200, Durham, NC 27701 USA | ©2021 FHI Clinical. All rights reserved.

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

FOLLOW US:FHIClinical@FHIClinical

Leverage our high-quality, end-to-end clinical trial services for your vaccine research.

Visit fhiclinical.com, email info@fhiclinical.com or call 919.321.3321.

CONTACT US

10+staff experience managing and coordinating domestic and international vaccine research

years

30+experience with global vaccine trials in our panel of scientific advisory experts

years

Site development, management and training

Site selection and assessment

Project management

Clinical monitoring

Data management

BiostatisticsLaboratory support

Safety and pharmacovigilance

Regulatory