Harvest Integrated Research Organization

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.

HiRO is purely a service provider — a clinical research organization that contracts directly with biotech and pharmaceutical sponsors. It does not operate as an investment fund or family office, and there is no evidence of direct equity participation in sponsor companies or trial assets.

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.

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.

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.