Clinical Data Science
Disciplined data and analysis that strengthen every decision.
CLARITY. CONSISTENCY. PREDICTABILITY.
The Modern Full-Service Global CRO
HiRO delivers the full range of clinical development services supported by global teams, regional insight, and biometrics-driven discipline. From startup to submission, we bring structure to complexity and clarity to every stage of your program – helping biotechs move with confidence and predictability.
Sponsors Trust HiRO’s Full-Service CRO Model
Biotechs choose HiRO because our teams operate on unified global standards, supported by regional expertise and a proven biometrics foundation. Every service – whether full study execution or functional support – is delivered through our Linkage™ Approach, ensuring consistency, transparency, and steady communication across every milestone.
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
Clinical Operations
Predictable, regionally informed study execution grounded in steady oversight, proactive site engagement, and disciplined coordination.
Quality Assurance
Inspection-ready governance with structured processes, continuous review, and documentation that stands up to scrutiny.
Medical Monitoring
Consistent clinical oversight with timely medical review, safety evaluation, and clear communication throughout your program.
Regulatory Affairs
Clear, compliant guidance supported by global standards, transparent documentation, and steady alignment with regional requirements.
Pharmacovigilance
Reliable safety oversight supported by disciplined case management, timely reporting, and globally aligned quality standards.
Medical Writing
Accurate, objective documents that translate complex data into clear, regulatory-ready narratives and submissions.
TAILORED FUNCTIONAL SUPPORT
Flexible FSP Services On A Global Scale
With consistent communication, stable coverage, and globally aligned standards, our Functional Service Provider (FSP) model strengthens your most critical functions while preserving flexibility. Biotechs gain the predictability of embedded expertise and the confidence of knowing every task is handled with care, rigor, and transparency.
Focused Expertise. Predictable Delivery.
HiRO’s FSP services give biotechs access to specialized teams in Clinical Data Science, Pharmacovigilance, and Medical Monitoring – without the burden of expanding internal infrastructure. Our experts integrate seamlessly into your workflows, bringing the same discipline, processes, and clarity that define our full-service approach.
Clarity That Strengthens Every Decision.
Our teams communicate with the calm, steady transparency biotechs rely on. Whether supporting a fullservice program or an FSP engagement, we provide clear expectations, structured updates, and guidance founded in real-time data. You get insight you can trust – and the confidence to move forward with clarity.
COMMON SERVICE QUESTIONS
Frequently Asked
Service Questions
What types of sponsors does HiRO work with?
HiRO works with biotech, pharmaceutical, and medical device sponsors that need a global, full service CRO to guide programs from IND stage planning through global clinical trial execution.
Which phases of clinical development does HiRO support?
HiRO supports the full clinical development lifecycle, from early development planning through post approval activities. Services span Phase I, II, III, and IV trials and include scientific, operational, and regulatory support at every stage. Post marketing support includes medical affairs, pharmacovigilance, and lifecycle management to ensure ongoing compliance and patient safety.
Can HiRO support both global trials and region specific clinical studies?
Yes. HiRO supports global, multi regional clinical trials as well as region specific studies. With operational presence across the United States, Europe, Asia Pacific, and Australia and New Zealand, HiRO combines globally aligned standards with deep regional expertise to navigate local regulations, authorities, and site networks while maintaining consistency across regions.
Can HiRO provide standalone services?
Yes. HiRO offers flexible standalone and functional services tailored to specific program needs. Sponsors can engage HiRO for targeted expertise or broader outsourcing support. This flexible model allows seamless integration with sponsor teams while maintaining quality, efficiency, and regulatory compliance.
How does HiRO deploy teams across regions to support clinical programs?
HiRO deploys integrated, cross functional teams that combine centralized global oversight with strong regional and local execution. Teams are structured to maintain consistent global standards while addressing country specific regulatory, operational, and cultural requirements. This approach enables scalable resourcing, real time communication, and reliable execution across North America, Europe, Asia Pacific, and Australia and New Zealand.
Let’s Build A Clear Path Forward.
