North America
* Confident * Flexible * Compliant * Consultative * Global
CLINICAL EXPERTISE ROOTED IN THE U.S. REGION
Purpose-Built for
U.S. Clinical Execution
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.
6.2
K+
Clinical Trials Conducted In The U.S. Every Year
4.5
M+
Patients Participate in U.S. Clinical Trials Every Year
35
K+
Clinical Trials Nationwide
~50
%
U.S. Represents Nearly Half Of All Global Trials
How We Support Oncology Programs Across the U.S.
See how HiRO stabilized and advanced a U.S.-based Phase I oncology program after a CRO transition, applying disciplined operational oversight, FDA-aligned processes, and steady site engagement. This case example highlights HiRO’s ability to restore momentum, maintain enrollment continuity, and deliver inspection-ready systems during active patient enrollment.
Successful Rescue and Transition of a Phase I Oncology Study
278
Patients enrolled within 12 months post-transition.
6.5
Weeks to complete CRO transition activities, including TMF, safety, and database migration.
WHAT SPONSORS GAIN IN THE U.S.
Regionally Executed.
Globally Aligned.
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.
Ready To Advance Your Study In The U.S.?