# Harvest Integrated Research Organization

Harvest Integrated Research Organization is an Asset Manager based in Shanghai, China.

## Overview

- **Organization type:** Asset Manager
- **Headquarters:** Shanghai, China
- **Region:** Asia
- **Address:** Shanghai, China
- **Assets under management:** Undisclosed
- **Website:** www.harvestiro.com
- **LinkedIn:** https://www.linkedin.com/company/harvest-integrated-research-organization

## Regulatory record

- **Reports private funds:** No

## About

Harvest IRO is a Modern Global CRO providing integrated clinical research organization services and regulatory-ready execution worldwide.

## Sectors

- Healthcare Services
- Enterprise Software

## Offices

- Somerset, NJ, United States
- Excelsior, MN, United States
- Beijing, China
- Taiwan
- Japan
- South Korea
- Malaysia
- Australia
- New Zealand

## People

- Karen Chu — Not specified
- Cristina Chang — Not specified
- Crista Casey — Chief Operations Officer

## Questions

### Who runs clinical operations at HiRO?

Crista Casey serves as Chief Operations Officer, bringing over 20 years of clinical operations leadership with deep experience in oncology, rare diseases, and advanced therapies. The broader leadership team includes regional heads like Jacquie Palmer (Australia/New Zealand via PharmaSols) and Xuedong Sun (APAC startup operations), creating a distributed but centrally governed ops function.

### How does HiRO structure its cross-border trial execution?

HiRO uses a proprietary HiRO Linkage™ framework that standardizes SOPs, data models, and governance globally while permitting regional adaptation. This contrasts with CROs that run independent country-level P&Ls; HiRO fields a single global project team with shared dashboards and decision frameworks to reduce handoff friction.

### Which therapeutic areas does HiRO concentrate on?

The firm's publicly highlighted expertise is strongest in oncology, rare diseases, cardiovascular, endocrinology, and infectious diseases. Senior medical monitors Valentina Zhukova-Harrill and Sheri Smith each have 25–30 years of oncology-specific trial experience, and the firm has contributed to at least two US FDA approvals.

### Does HiRO handle regulatory submissions across APAC?

Yes. Becky Lu leads a 55-member APAC regulatory affairs team spanning Mainland China, Taiwan, Korea, Malaysia, the Philippines, and Thailand. JiHee Noh separately runs South Korea regulatory operations and has secured top-three rankings in MFDS IND approvals multiple times, including in 2023.

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Last updated: 2026-06-03T20:00:00.000Z

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