The United States sets the global benchmark for clinical development, particularly in oncology, with rigorous FDA oversight, experienced investigators, and advanced research infrastructure. HiRO supports U.S.-based studies within a unified global framework—helping sponsors navigate regulatory pathways, activate capable sites, and maintain steady momentum across early-phase and complex programs.

Our teams apply global oncology standards, biometrics discipline, and medical oversight while aligning execution to U.S. regulatory expectations. Through consistent communication and transparent processes, sponsors gain clarity, reduced risk, and confidence that decisions are grounded in real-time data and proven U.S. execution.

HiRO brings its global oncology framework into the U.S. through disciplined clinical data science, coordinated medical monitoring, and operational execution aligned with FDA expectations. Sponsors benefit from structured IND planning, experienced oncology investigators, and site networks capable of supporting complex protocols.

Through our HiRO LINKAGE™ Approach, U.S. execution connects seamlessly with global standards—ensuring consistency across regions while preserving the flexibility needed to navigate local requirements. The result is predictable delivery, transparent communication, and oncology programs that scale confidently from the U.S. into global development.