North America
BIOTECHS DEMAND DISCIPLINE, CLARITY, AND DEPTH
Oncology Expertise Rooted In Rigor, Insight, and Precision
Oncology studies demand a level of discipline, clarity, and scientific depth that few CROs can consistently deliver. HiRO’s oncology teams bring together global experience, regional insight, and biometrics-led precision to guide each study with calm, evidence-driven confidence.
Through our HiRO Linkage™ Approach, we connect people, systems, and data into a unified framework—helping sponsors navigate complexity, anticipate challenges, and move forward with decisions grounded in evidence, not assumption.
Our experience is more than perspective. It’s reflected in the oncology programs we’ve supported worldwide—from early-phase exploration through late-phase confirmation—delivering the consistency, structure, and clarity modern oncology development demands.
Oncology Indicators
HiRO supports a broad range of oncology programs across solid tumors, hematologic malignancies, and all-comers designs. Our teams are experienced in complex protocols, biomarker-driven studies, and multi-regional oncology trials requiring disciplined execution and regulatory alignment.
Solid Tumors
- Lung Cancer
- Breast Cancer
- Ovarian Cancer
- Pancreatic Cancer
- Colorectal Cancer
Hematologic Malignancies
- Leukemia
- Multiple Myeloma
- Lymphomas
Oncology – All Comers
Oncology Experience By The Numbers
Our oncology experience spans early-phase exploration through late-phase confirmation, supported by biometrics rigor and regionally aligned execution. These numbers reflect the scale, consistency, and quality sponsors rely on as programs grow in complexity.
125
Team Members With Direct Experience
130
Oncology Studies
870
Global Oncology Sites
6K
Patients
How HiRO Restored Momentum in a Phase I Oncology Program
See how HiRO stabilized and advanced an active Phase I oncology study following a CRO transition, applying disciplined biometrics, inspection-ready oversight, and steady investigator engagement. This case highlights HiRO’s ability to protect enrollment, maintain patient safety, and restore sponsor confidence in high-pressure oncology programs.
Rescue and Transition of a Phase I Oncology Study
15
Total oncology sites transitioned during active enrollment.
5
Additional oncology studies awarded following successful Phase II expansion.
DISCIPLINE MEETS ADAPTIVE EXECUTION
A Modern Approach
To Oncology
Oncology trials require a partner who can bring structure to complexity and clarity to every decision. As protocols grow more intricate and timelines tighten, sponsors need guidance that is both disciplined and steady. HiRO brings biometrics rigor, transparent communication, and thoughtful oversight together—helping teams move through each stage with confidence.
By combining global operational strength with regional oncology insight, we ensure every program benefits from unified standards and deeply connected teams. Through our HiRO Linkage™ Approach, oncology studies advance with aligned expectations, consistent communication, and the collective wisdom of shared global experience.
Confident Pathways
To IND
We don’t just manage timelines—we help oncology sponsors navigate the full regulatory journey with confidence. From early strategy through IND submission and beyond, HiRO supports oncology programs with regulatory-aligned planning and globally informed execution.
Proactive Planning: Anticipating challenges before they become delays.
Integrated Approach: Aligning clinical, regulatory, and operational strategies.
Global Perspective: Supporting multi-regional programs and diverse regulatory expectations.
Collaborative Partnership: Working side-by-side to ensure clarity and compliance.
Our goal is simple: help oncology programs move from concept to clinic efficiently—without compromising quality, rigor, or regulatory confidence.
Book A Meeting Today With
Our Oncology Team