Elite team+Global strategy+Flexibility & Integration

HiRO Five High

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ABOUT HIRO

Harvest Integrated Research Organization (HiRO) is a China-based globally oriented clinical research organization (CRO) with its headquarters in Shanghai, China.

With global operations and integration capabilities, the company is dedicated to providing its clients with a full range of solutions and services. HiRO strives to become a market-leading, integrated global clinical research organization that works hand-in-hand with biotech companies 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

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

Led by OrbiMed, HiRO Raised Tens of Millions of US Dollars in Series A Financing, to Offer Multinational Global Clinical Development Strategy

HiRO announced the completion of its Series A financing in the tens of millions of US dollars. This round of investment is led by OrbiMed, with the participation from existing shareholder, Fontus Capital.