Human challenge trials
Need confidence before moving your vaccine or antiviral into costly field studies? Generate early human efficacy data before larger trials.
SGS designs and conducts CHIM studies that help evaluate vaccines and antivirals in healthy volunteers under controlled clinical conditions.
Experience that runs deep
We bring 40+ years of early clinical trial expertise, including infectious diseases, first-in-human studies, complex PK/PD and human challenge testing.
Accelerated Belgian timelines
Antwerp CHIM hub
We are part of a mature CHIM ecosystem in Antwerp, where clinical pharmacology, quarantine capacity, GMP support, labs and complementary CHIM units are located close together.
A favorable regulatory environment in Belgium with very short approval timelines for mononational CHIM studies (59 days from submission, incl. RFI)
State-of-the art facility
Our Clinical Pharmacology Unit in Belgium includes specialist quarantine facilities with BSL-2 capabilities, with containment, control and participant safety built into the operational setup.
When you need to be sure
Ready to de-risk your vaccine or antiviral program?
Our human challenge trial experts will help you explore the right CHIM study approach.
Jelle Klein
Medical Director, SGS
Pharmaceutical company
Client
When there’s an SGS writer on the team, it’s a relief. They bring clarity and stability where it’s most needed.
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How we can support you
Study strategy and design
Feasibility assessment, CHIM study design, endpoint selection, protocol input and go/no-go planning.
Challenge model and agent support
Access to validated challenge models, including influenza H3N2, RSV-NICA, rhinovirus and malaria.
Volunteer recruitment and screening
Healthy volunteer recruitment, prescreening and selection against complex inclusion and exclusion criteria.
Clinical conduct
Human challenge study execution in specialist quarantine facilities, with controlled inoculation, monitoring and safety oversight.
Sampling, labs and biomarkers
Rapid sample processing, viral shedding analysis, symptom scoring, immune monitoring, PK/PD and biomarker assessments.
Data for development decisions
Regulatory-ready data packages to support early efficacy, proof of concept, proof of mechanism and future field trial design.
We support controlled human infection model (CHIM) studies that help you assess proof of concept, safety, viral kinetics, immune response and early efficacy signals under carefully controlled conditions.
With known inoculation timing, intensive monitoring and high-quality sample processing, CHIM studies help reduce uncertainty, sharpen go/no-go decisions often before large, variable and expensive field trials. SGS uses this model for infectious disease programs including influenza, RSV, malaria and human rhinovirus.
De-risk through CHIM studies
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About SGS Clinical Research
We're a mid-sized, full-service CRO specialized in early-phase development and biometrics. We offer drug development consultancy, project management, monitoring, data management, statistics, medical writing, safety and regulatory services. We have our own clinical pharmacology unit in Belgium featuring a viral challenge facility and have access to patients through our site network with 400+ sites. Our key therapeutic areas include infectious diseases, vaccines, respiratory, dermatology and oncology.
