Skip to main content

Modern Global
CRO Support
Across APAC

(Scroll)

Global clinical excellence, delivered through APAC regulatory fluency and regionally linked execution.

HiRO APAC Region

CLINICAL EXPERTISE ROOTED IN APAC

Purpose-Built for
APAC Clinical Execution

APAC offers diverse trial environments—from high-enrollment markets to data-quality anchor countries—making it essential to align each study to local requirements while preserving global standards. HiRO supports clinical programs across APAC with a unified global framework, helping sponsors navigate regional regulations, activate capable sites, and maintain momentum across early-phase and complex studies.

Our teams bring deep experience across APAC regulatory agencies—including NMPA (Mainland China), TFDA (Taiwan), PMDA (Japan), MFDS (South Korea), FDA (Philippines), NPRA (Malaysia), and HSA (Singapore) —while linking operations to HiRO’s global clinical data science and medical oversight. Sponsors gain clear regulatory direction, consistent communication, and execution that stays aligned as programs scale across regions.

How We Support Clinical Study Delivery Across APAC

See how HiRO applied global standards and region-specific regulatory planning to support APAC trial execution across multiple countries. This case example highlights structured startup pathways, disciplined oversight, and the clear sponsor communication required to run APAC programs with confidence.

APAC IRO Company

Rescuing a Rare Disease Trial

Download Case Study
1.5

Months to deliver first regulatory and IRB submissions within 1.5 months of project takeover.

18

Expanded the program across 18 countries and regions through proactive MRCT regulatory planning.

WHAT SPONSORS GAIN IN APAC

Regionally Executed.
Globally Aligned.

HiRO helps sponsors match the right APAC countries to the right trial goals—whether prioritizing enrollment scale, early-phase specialization, data quality, or operational efficiency. Across markets, we support regulatory strategy, ethics planning, site activation, and monitoring in ways that reflect local workflows while staying aligned to global expectations.

Through our HiRO LINKAGE™ Approach, APAC country expertise connects directly to HiRO’s global standards —so oncology and complex programs remain consistent across sites, datasets, and teams. Sponsors gain predictable execution, transparent reporting, and confidence that regional decisions support a coherent global development path.

Mainland China

A high-enrollment market with modernized regulation aligned to ICH-GCP and strong capabilities in oncology, immunology, rare disease, and advanced therapies. HiRO helps sponsors plan NMPA/CDE submissions, parallel ethics reviews, and disciplined site activation to support efficient early and late-phase execution.

NMPA / CDE Pathways

Taiwan

A stable, predictable environment with strong hospital infrastructure and globally accepted data when aligned to ICH standards. HiRO supports TFDA readiness, efficient startup planning, and reliable trial delivery across oncology, vaccines, metabolic, and rare disease programs.

TFDA Readiness

Japan

A strategic market with rigorous expectations and strong integration into multinational and multiregional trials. HiRO supports PMDA consultation planning, CTN readiness, and high-quality execution aligned to global submission standards—especially for oncology, regenerative medicine, and rare disease programs.

PMDA Strategy

South Korea

A globally recognized clinical trial hub with rapid timelines, digitally enabled infrastructure, and strong MRCT performance. HiRO supports MFDS pathways and streamlined startup planning while sustaining global-quality data and consistent operational oversight.

MFDS Acceleration

Philippines

A high-recruitment environment well-suited to late-phase and high-volume programs, including infectious disease and vaccine trials. HiRO supports Philippine FDA + ethics routing, startup coordination, and audit-ready execution with clear communication across stakeholders.

High-Volume Enrollment

Malaysia

A reliable, English-speaking environment with predictable regulatory processes and strong performance in chronic disease and oncology studies. HiRO supports NPRA/MREC coordination, experienced site engagement, and efficient trial operations with ICH-GCP alignment.

NPRA / MREC Timelines

Singapore

A high-trust biomedical hub with efficient HSA timelines and exceptional data quality—ideal for early-phase, high-complexity, and precision medicine programs. HiRO supports HSA CTA planning, institution-based ethics workflows, and rapid site activation so APAC execution stays aligned with global submission expectations.

HSA Efficiency & Data Quality

Ready To Advance Your Study In APAC? Let’s Explore What’s Possible.

Book A Meeting