North America
ABOUT HiRO AND OUR DISRUPTIVE APPROACH
More Than A CRO:
A Calculated Acceleration
From the beginning, HiRO was designed to be more than a traditional CRO. One where agility and rigor live in harmony, and biotechs can rely on a global team of expertise, helping to navigate studies and data seamlessly.
WE ARE NOT YOUR TYPICAL CRO
A Modern Full-Service
Global CRO
Clinical development is evolving – demanding faster decisions, cleaner data, and transparent communication at every step. Enter HiRO, designed for this moment. As The Modern CRO, we scale with intention, structure our processes around strong biometrics foundations, and move with the kind of clarity that lets sponsors stay ahead of risk.
What sets HiRO apart is how our teams, systems, and data work together. We operate as a fully integrated, full-service global CRO—linking regulatory strategy, clinical data science, clinical operations, medical monitoring, and quality into a unified execution model. This connection creates consistency across regions, surfaces risk earlier, and replaces fragmented handoffs with disciplined collaboration biotechs can trust.
MEET OUR TEAM
Global
Experts
Dedicated Professionals Looking To Make An Impact Across The Globe
- 20+ years of international CRO management and operational experience.
- A top international executives in the industry, supervised 600-800 clinical trials annually, led a global clinical team of 5,700+ professionals across 55 countries.
- Broad experience in cross-regional mergers, personnel and business development.
- Conducted due diligence on biotech/medical device companies, and serves as aboard member for a global biotech company.
- 23 years of industry experience across CRO, biotech, and site perspectives, with a strong focus on building high-performing teams and departments while consistently meeting high-quality standards expected by clients.
- Extensive expertise collaborating with biotech clients, understanding their unique needs, and supporting their efforts to achieve corporate milestones and accelerate project timelines.
- Proven management experience spanning clinical operations, project management, and biometrics, ensuring efficient and seamless project delivery.
- Over 30 years’ experience within multi-national pharmaceutical and CRO industries, with a holistic understanding of all aspects of drug development.
- Grown PharmaSols to be an extremely successful Australia and New Zealand focused CRO.
- Successfully operated full-service clinical institutions from phase I to IV in the local area, covering cardiovascular, oncology, blood diseases, endocrine, respiratory and neurological diseases.
- Seasoned executive with over 25 years of industry experience balanced between pharmaceutical and CRO companies, with the various leadership role in biometrics function across US and APAC.
- Extensive experience in overall business operations, business development, process excellence, resource management and particularly with effective solution-oriented client communication and decision making.
- Expert in clinical data including design, analysis and regulatory communications across various therapeutic areas and indications.
- MD PhD in medicine and surgery, 20+ years of experience in industry and clinical setting.
- Expertise in Drug Development, Regulatory Strategy and Medical Sciences/MW/PV, leading to successful IND/NDA/MAA worldwide.
- 15 years of experience in multinational pharmaceutical companies and CROs, cross-functional leadership skills in diverse therapeutic areas (phases I-IV and IIT studies).
- Extensive knowledge in global and Greater China regulatory affairs.
- Over 17 years of commercial leadership experience across multiple regions, including key senior roles at leading CROs.
- Strong background in building, scaling, and transforming emerging organizations into recognized industry leaders.
- Deep understanding of the key challenges faced by biotech companies, especially in accelerating timelines, reaching critical milestones, advancing innovative therapies, and maximizing patient impact.
- 20+ years of project management and operations experience, serving top-tierinternational CROs.
- Managed 200+ project managers and clinical operations professionals across 26 countries, including the US, Latin America, Europe, and Asia.
- Served as a strategic consultant for 35 key clients, and completed 110+ projects, assisting in the expansion of the company’s overseas business in Asia, including Japan.
- Results-oriented and strategic minded individual with more than 20 years of experience in clinical research across APAC, EMEA, LATAM and US.
- Proven track record in overseeing clinical deliverables, driving process improvements with physical operational experiences in Australia, Mainland China, Taiwan and Ireland.
- Experienced Head of Clinical Affairs and Operations Globally with a demonstrated history of working in In-vitro diagnostic, CRO and pharmaceuticals industry.
- Over 30 years of experience in the pharmaceutical and clinical research industry.
- With 21 years of experience at three international pharmaceutical companies, held key roles in drug development, project management, clinical research, pre-clinical studies, and regulatory affairs.
- Another 12 years of experience at two global CROs, overseeing client relationship development, clinical operations, and FSP/Dispatch business.
- Over 30 years of clinical trial management experience in pharma and niche CRO; over 25 years in oncology product development.
- Experienced with compiling IND and NDA submissions for FDA.
- Initiated and executed international phase 1-4 trials for oncology therapeutics.
- 15 years in the clinical research industry with varied experience in Clinical Operations, Training and Compliance, Quality Assurance, Project Management and Monitoring experience in Europe and APAC Countries.
- Experience on several therapeutics’ areas such as Oncology, Psychiatry, Endocrinology, Infectious Diseases, Endocrinology, Rheumatology, Medical Device and Vaccines.
- Former President of Philippine Clinical Research Professionals (PCRP) (2021-2023).
- 12+ years of experience in quality management and data operations in the fields of CRO and pharmacutical.
- Extensive expertise in establishing quality management systems, process optimization, and overseeing audits/inspections.
- Supervised, co-audited, and provided support for 30 inspections and internal/external audits in the US, EU, and APAC.
- 18 years of clinical operations and management experience in global CROs and pharmaceutical companies.
- Former head of clinical startup department in a multinational CRO, overseeing 100+ staff in Greater China, Korea, the Philippines, Thailand, and other APAC countries.
- Comprehensive experience in project and clinical operations management; strong focus on progress and quality control.
- 20+ years of experience in pharmaceutical companies, global CROs, and venture capital, covering regulatory consulting, strategy, planning, execution, post-investment management and due diligence.
- 17+ years of regulatory affairs experience in APAC, managing teams of 55 members in Mainland China, Taiwan, Korea, Malaysia, the Philippines, and Thailand.
- Responsibilities include providing regulatory consultancy and managing submissions for clinical and drug registrations in APAC.
- Over 13 years of experience in the global pharmaceutical and CRO industry.
- Extensive expertise in regulatory operations, including NDA submissions, IND submissions, GMP inspections, gap analysis, and more.
- Has a remarkable career record of leading regulatory teams, overseeing start-up operations, and achieving significant milestones in regulatory approvals, including securing Top 3 rankings in Korea’s HA (MFDS) IND Approvals on multiple occasions, including in 2023.
- 18 years of data science operational and management experience in top-tier global CROs.
- Led teams of 90+ professionals in clinical data operations, medical coding, and clinical data programming, supporting 150+ clinical studies.
- Dedicated to solutions in data statistics services, process automation, and data visualization.
HiRO LINKAGE™ IS MORE THAN A FRAMEWORK
HiRO LINKAGE™ Is Our Approach As The Modern Global CRO
A unified global operating model built to give biotechs clarity, predictability, and speed–the pillars needed for a successful study.
Focus : People
Integrated global teams who think, act, and deliver as one. HiRO deploys cross-regional teams aligned under shared expectations, communication rhythms, and decision-making models.
Biotech Value
- Consistent experience across regions
- Faster issue resolution
- No “handoff gaps” between countries
- A single accountable team driving outcomes
Focus : Systems
Shared technologies and data platforms that keep every region working in sync. From EDC to CTMS, to analytics environments, every team operates inside a common tech ecosystem.
Biotech Value
- Harmonized data from day one
- Easier oversight and audit readiness
- Faster study start-up
- Reduced system variability and rework
Focus : Processes
Standardized global SOPs that guide every study with discipline and predictability. Processes are built once at the global view, then adapted regionally without breaking consistency.
Biotech Value
- More predictable timelines
- Higher quality outputs
- Repeatable excellence across studies
- Confidence that every task follows the same standard
Focus : Oversight
A single global governance model that ensures accountability and transparency. HiRO’s oversight structure aligns global and regional leads, using shared dashboards and decision frameworks.
Biotech Value
- Clear visibility into progress and risks
- Proactive intervention before delays occur
- One governance rhythm across all regions
- Fewer surprises, more predictability
Focus : Data
Unified data definitions, models, and review tools that deliver consistency at every stage. Data is structured and analyzed the same way globally, enabling faster insights and earlier pattern detection.
Biotech Value
- Cleaner, more actionable data
- Faster interim analyses
- Seamless integration across regions
- Confidence in global data integrity
Focus : Collaboration
A cross-regional culture of transparency, communication, and shared problem-solving. Linkage eliminates silos by creating global communication frameworks and cross-time zone workflows.
Biotech Value
- Smoother global execution
- Faster alignment on decisions
- More efficient study operations
- A partnership based on clarity, not complexity
We Are Problem-Solvers Seeking Answers To Life’s Greatest Challenges.
UNIFIED BY A COMMON SET OF VALUES
The Core Values
That Link Us
Guided By Purpose
Every decision we make links back to one priority: improving patient lives. Our work exists to advance better treatments, support global health, and ensure that the people behind every data point are never forgotten.
Truth In All We Do
Integrity connects our people, processes, and partnerships.
We operate with transparency, honesty, and ethical discipline — creating trust in our data, our communication, and our commitments.
Excellence Through Discipline
Quality is the framework that links our systems and our outcomes.
Through rigorous processes and adaptable problem-solving, we deliver reliable, audit-ready work that sponsors can depend on from startup through submission.
Wisdom Through Collaboration
Strong teams create strong linkage across regions, disciplines, and sponsors. We invest in continuous learning, shared accountability, and collaborative culture so every project benefits from aligned, high-performing people.