CRS conducts Bridging and Phase I–IIa studies within its dedicated early-phase clinical research unit, supporting the transition from early human exposure to initial assessments of clinical activity. These studies are designed to generate critical data that links prior development stages and informs progression into later-phase programs.

We support a wide range of bridging strategies, including formulation changes, route-of-administration transitions, population bridging, and regional development programs. Phase I–IIa designs may incorporate multiple dose levels, exploratory efficacy endpoints, and pharmacodynamic assessments, requiring close coordination between safety monitoring and early efficacy evaluation.

CRS manages the full operational conduct of in-house bridging and Phase I–IIa studies, including subject or patient recruitment, dosing, inpatient and outpatient visits, and protocol-defined assessments. Our facility supports flexible study designs, allowing adaptation based on emerging safety, pharmacokinetic, or pharmacodynamic data while maintaining strict protocol compliance.

Clinical activities are fully integrated with pharmacovigilance, regulatory affairs, data management, and project management teams. This enables real-time review of accumulating data, efficient implementation of protocol amendments, and timely decision-making during study progression.

By combining dedicated early-phase infrastructure, experienced multidisciplinary teams, and an integrated CRO model, CRS delivers bridging and Phase I–IIa studies that reduce development uncertainty and support confident advancement into later clinical phases.