SGS | Human Challenge Trials

Benchmark Clinical Pharmacology Facilites

Specialist R&D quarantine facilities SGS’s hospital-embedded, Human Challenge Unit (HCU) consists of a specialized 30 bed isolation unit and a 16 bed isolation unit that are certified to Biosafety Level 2 (BSL2). The quarantine units are HEPA-filtered and operate under negative pressure (HVAC) as well as being equipped according to international, benchmark standards with the latest technologies for remote monitoring.

SGS’s Clinical Pharmacology Unit has a total of 110 hospitalization beds and has successfully completed several US FDA, FAMHP inspections and numerous client audits over the past 5 years. For optimized early phase clinical trials, SGS features:

Volunteers are provided with either individual, en-suite or ward-style cubicles according to study requirements. The challenge facility is served by a dedicated clinical trial laboratory equipped with PCR, cell-counters, a flow cabinet, acid cabinet and with dedicated systems and workflows to safely handle infectious samples. The laboratory has HEPA-filtered exhaust systems and an airlock to prevent cross-contamination or accidental release of agents.

Check out our Clinical Pharmacology Services

• GCLP laboratory within the unit for rapid sample processing e.g. PBMC preparation • Full eSource clinic automation (EDC) including

sample tracking for safety lab data • Biosafety Level 2 quarantine facility • GMP pharmacy for on-site formulation

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