CRS conducts in-house First-in-Human (FIH) studies within its dedicated early-phase clinical research unit, offering sponsors a controlled environment with intensive medical oversight for the safe initiation of clinical development. Our infrastructure and teams are purpose-built to manage the complexity and risk inherent to first administration of investigational medicinal products in humans.

We support a wide range of FIH study designs, including single ascending dose and multiple ascending dose cohorts, sentinel dosing, and adaptive escalation strategies. All studies are conducted with continuous medical supervision, immediate access to experienced investigators, and clearly defined safety escalation and stopping rules. This approach ensures rapid identification and management of emerging safety signals.

CRS manages the full operational execution of in-house FIH studies, including subject recruitment and screening, dosing, inpatient confinement, intensive pharmacokinetic sampling, and real-time safety monitoring. Our unit is equipped to support complex protocols requiring close observation, frequent assessments, and rapid data turnaround to inform dose-escalation decisions.

FIH activities are fully integrated with pharmacovigilance, regulatory affairs, and project management functions. Safety data review, sponsor communication, and decision-making processes are coordinated in real time to support timely and informed progression through dose levels.

By combining specialized early-phase infrastructure, experienced FIH teams, and an integrated CRO model, CRS delivers First-in-Human studies that prioritize participant safety, regulatory compliance, and the generation of reliable early clinical data.