Vaccine Development: Stay Two Steps Ahead with FHI Clinical
Transcript of Vaccine Development: Stay Two Steps Ahead with FHI Clinical
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:[email protected]
FOLLOW US:FHIClinical@FHIClinical
Leverage our high-quality, end-to-end clinical trial services for your vaccine research.
Visit fhiclinical.com, email [email protected] 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