Improve efficiency and reduce risk with comprehensive support for designing and conducting controlled human infection model (CHIM) trials.
While early phase pharmacological trials focus on safety and pharmacokinetics, human challenge trials (HCT) support proof of concept (POC) for your investigational medicinal product (IMP). In a Controlled Human Infection Model (CHIM) study, a well characterized strain of pathogen (virus, bacteria,..) is administered at a controlled dose (before or after administration of IMP) and by a specific route to carefully selected healthy volunteers. Continuous monitoring results in maximizing trial data in limited subjects and in the short run. These innovative studies enable you to reduce the timelines of POC from years to months, decrease costs related to number of subjects and clarify the ability of the compound to reach the market.
We conduct comprehensive HCT and CHIM studies at our state-of-the-art clinical pharmacology unit (CPU). Our dedicated team of medics and experts provide continuous monitoring and utilizing our high tech CL2 laboratory allows qualitative sample processing and storage. Several leading infection control features, including negative pressure, HEPA-filtering and airlock systems, highlight the innovative quarantine status of the unit.
We work in close collaboration with a wide variety of academic research organizations and scientific suppliers of challenge agents to ensure your trials are conducted safely and with the maximum focus on outcomes.
SGS is recognized as the benchmark for quality and integrity in HCT and CHIM trial design and supervision. Whatever your requirements, we will help you get the most out of your trial while ensuring regulatory compliance and the safety of all stakeholders.