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BIOTECHS DEMAND CLARITY, PRECISION, AND CONFIDENCE

Metabolic Expertise Built for Complex, Data-Driven Decisions

IRO Metabolic HiRO

Metabolic studies demand more than execution—they require scientific fluency, data integrity, and disciplined coordination across endpoints, populations, and timelines. HiRO’s metabolic teams bring together global therapeutic expertise, advanced clinical data science, and steady operational oversight to guide programs with clarity and confidence.

Through our HiRO LINKAGE™ Approach, we connect people, systems, and data into a unified framework—helping sponsors anticipate challenges, reduce uncertainty, and make evidence-based decisions without compromising scientific rigor.

HiRO Metabolic
IRO Metabolic HiRO

From early-phase innovation through late-phase validation, our metabolic experience reflects a consistent ability to translate complexity into actionable insight and reliable progress.

Metabolic Indications

HiRO supports a broad range of metabolic and endocrine programs, with experience spanning glycemic control, cardiometabolic risk, and complex liver and endocrine disorders.

Diabetes & Glycemic Disorders

  • Type I Diabetes
  • Type II Diabetes
  • Hypoglycemia · Diabetic Complications

Hepatic & Metabolic Liver Disease

  • Non-Alcoholic Steatohepatitis (NASH)

Cardiometabolic Risk

  • Obesity
  • Hypertension
  • Dyslipidemia

Endocrine Disorders

  • Hyperthyroidism

Metabolic Experience by the Numbers

Our metabolic experience spans early-phase exploration through late-phase confirmation, supported by disciplined data practices and globally coordinated execution. These results reflect the reliability, depth, and operational consistency sponsors rely on when metabolic studies demand accuracy across multiple endpoints and long-term timelines.

215

Sites Globally

2.3K

Patients Enrolled

How Disciplined Execution Strengthened a Phase II Metabolic Program

Explore how HiRO supported a Phase II obesity trial through structured site selection, proactive retention strategies, and steady operational oversight. This case study illustrates how metabolic programs benefit from integrated planning, real-time issue resolution, and regionally aligned execution.

HiRO Oncology Study

Exceeding Recruitment Targets for a Phase II Obesity Trial

Download Study
101

Of enrollment target achieved (327 of 325).

1

Day from site activation to first patient visit.

DISCIPLINE MEETS ADAPTIVE EXECUTION

A Modern Approach to Metabolic Studies

Metabolic programs require a partner who can bring structure to complexity and adaptability to evolving data. With protocols spanning multiple endpoints and timelines under pressure, sponsors need guidance that is both disciplined and flexible.

HiRO combines biometrics rigor, transparent communication, and thoughtful oversight to help teams move through each stage with confidence. By integrating global operational strength with deep metabolic insight, every program benefits from unified standards and deeply connected teams.

Regulatory Confidence, End-to-End

We don’t just manage timelines—we help metabolic sponsors navigate the full regulatory journey with confidence. From early strategy through IND submission and beyond, our teams bring practical experience across global regulatory expectations.

Proactive Planning: Anticipating risks before they impact timelines

Integrated Execution: Aligning clinical, regulatory, and operational strategy

Global Perspective: Supporting multi-regional development with consistency

Collaborative Partnership: Working side-by-side to ensure clarity and compliance.

Our Goal: To help you move from concept to clinic efficiently—while maintaining the highest standards of quality, compliance, and data integrity.

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Our Metabolic Team

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