Elite team+Global strategy+Flexibility & Integration Elite team+Global strategy+Flexibility & Integration

Elite team+Global strategy+Flexibility & Integration

HiRO Five High HiRO Five High

HiRO Five High

. .




Harvest Integrated Research Organization (HiRO) is a globally-oriented, innovative clinical research organization (CRO). 

With global operations and integrated capabilities, HiRO provides a full range of cross-border solutions and services to its clients, including early pre-clinical strategic planning, clinical trial design, regulatory affairs, pharmacovigilance, statistics, data management, end-to-end project management, and clinical and medical monitoring services. As an emerging global CRO, HiRO strives to work collaboratively with biotech and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide.





Oncology &

10+ years of Industry

  • Project Management
    Project Management
  • Clinical Science and Medical Affairs
    Clinical Science and Medical Affairs
  • Quality and Audit
    Quality and Audit
  • Clinical Operation
    Clinical Operation
  • Regulatory Affairs and Strategy
    Regulatory Affairs and Strategy
  • Data Operation
    Data Operation
  • Project Management

    • Regional project management & international project management

    • Develops senior operational relationship and sets operational strategy

    • Overall project planning and consulting

    • Overall service from protocol design to clinical report

    • CRO management and oversight

  • Clinical Science and Medical Affairs

    • Medical Monitoring

    • Medical Writing (Protocol, IB, ICF and CTD, etc.)

    • Pharmacovigilance

    • KOL Engagement

    • NMPA/CDE Meeting

    • Training

    • Medical Consultation & Strategy

    • CDP

  • Quality and Audit

    • QMS Establishment

    • SOP Gap Analysis

    • GCP Training

    • Clinical Trial Audits

    • Risk-based Quality Management

    • Quality Issue Management

  • Clinical Operation

    • Feasibility Study

    • Clinical Monitoring

  • Regulatory Affairs and Strategy

    • Regulatory Strategy/Consultation Meeting

    • Clinical Trial Application and Life Cycle Management

    • New Drug Application and License Life Cycle Management

  • Data Operation

    • Clinical Data Management

    • Biostatistics

    • Statistical Programming


  • Elite Team

    We are a group of CRO veterans who have been developing therapies for the last 20 years in top international CROs and pharmaceutical enterprises. 

  • 解决方案
  • Global Strategy

    HiRO’s most distinctive strength is in managing multinational clinical development projects, and providing multinational regulatory strategic consulting. HiRO’s mission is to develop ideal global expansion plans to accelerate our clients’ projects and reach their goals.

  • 解决方案
  •  Flexibility & Integrity

    ♦ We offer one-stop service, with integrated processes and systems to provide the best possible outcomes to our clients.

    ♦ Our team has adopted the highest quality global standards while providing flexible collaboration models that fits our clients’ needs.



Harvest Integrated Research Organization (HiRO) is a CRO that serves both Asian biotechs looking to do clinical trials outside of the region, and US and European clients wanting to conduct clinical research in Asia. CEO and founder Karen Chu explains the company’s integrated approach and how it aims to maintain its “boutique” style while undergoing major expansion into Australia, New Zealand, the US, and South Korea. She also discusses the recent surge in clinical trials in the APAC region and the increasing quality of the data generated there.
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A biotech sponsor based in China was conducting a clinical study on COVID-19 treatment in the United States and the Asia Pacific region, including China, in collaboration with a global contract research organization (CRO). 6 months into a new study start, facing site activation and patient recruitment challenges, biotech changes CRO and HiRO rescues Vaccine study.
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Harvest Integrated Research Organization (HiRO), an innovation global CRO, is pleased to announce the successful acquisition of Courante Oncology, a US-based full-service clinical research provider specializing in oncology product development.
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Harvest Integrated Research Organization (HiRO) is proud to announce that the highly regarded global pharmaceutical publication "Pharma Tech Outlook" named HiRO among the Top 10 CROs in Asia and the Pacific. 
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Tel:+86 21 62191220

Email :info@harvestiro.com


Mainland China
​▪ Shanghai: 33C2, Zhongyi Building, No. 580 Nanjing West Road,
​▪ Beijing: Room 1203B-1204A, China Life Tower, No.16
  Chaoyangmen Wai Street, Chaoyang  District, Beijing
​▪ 3F-9, No 510, Sec 5, Zhongxiao E. Rd, Taipei 110058
Australia/New Zealand
​▪ Level 1, The Levy Building, 20 Customs Street East Auckland, 1010,
  New Zealand

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