Elite team+Global strategy+Flexibility & Integration

HiRO Five High

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ABOUT HIRO

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.

Efficiencies driven
by Expertise

Fully leveraging
Data and AI

Engineered Model to
service pharma and biotech

Pioneering new R&D Innovations
(virtual trials, wearables,
bio-simulation, etc.)

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Global
Experience

Oncology &
Immunology

10+ years of Industry
Experience

Project Management

Clinical Science and Medical Affairs

Quality and Audit

Clinical Operation

Regulatory Affairs and Strategy

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

SOLUTIONS
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.
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.
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.

NEWS

HiRO CEO Dr Karen Chu Interviewed by PharmaBoardroom

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.

Case Study: Rescuing Vaccine study, achieving milestone 3 months early

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.

HiRO Acquires US CRO Courante Oncology, Strengthens Global Footprint and Operation Capabilities

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.

Pharma Tech Outlook Names HiRO as Top 10 CROs in APAC 2022

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.

WE ARE HIRING

HiRO PARTNERS

Tel：+86 21 62191220

Email ：info@harvestiro.com

Add：

Mainland China
▪ Shanghai: 33C2, Zhongyi Building, No. 580 Nanjing West Road,
Shanghai
▪ Beijing: Room 1203B-1204A, China Life Tower, No.16
Chaoyangmen Wai Street, Chaoyang District, Beijing
Taiwan
▪ 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

By 300.cn

ABOUT HIRO

搜索

Project Management

Clinical Science and Medical Affairs

Quality and Audit

Clinical Operation

Regulatory Affairs and Strategy

Data Operation

Project Management

Clinical Science and Medical Affairs

Quality and Audit

Clinical Operation

Regulatory Affairs and Strategy

Data Operation

SOLUTIONS

NEWS

HiRO PARTNERS