# HiRO - Harvest Integrated Research Organization

> HiRO (Harvest Integrated Research Organization) is a full-service, globally oriented clinical research organization founded in 2020 that helps biotech companies run clinical trials across borders. Positioning itself as an 'integrated' rather than a traditional 'contract' research organization, HiRO connects Asian biotechs seeking trials outside their region with US and European sponsors wanting to run studies in Asia. Backed by a tens-of-millions-of-dollars Series A led by OrbiMed and built out through three CRO acquisitions, it offers end-to-end services from preclinical strategy to regulatory submission, with deep expertise in oncology and rare disease.

- **Founded:** 2020
- **Headquarters:** Somerset (Somerset/Franklin Township), New Jersey, United States
- **Founders:** Karen Chu (Founder & CEO)
- **Team size:** ~110 employees
- **Products:** Clinical Data Science, Regulatory Affairs, Clinical Operations, Pharmacovigilance & Medical Safety, Medical Writing & Medical Monitoring
- **Notable:** Grew from founding in 2020 to operations across roughly ten countries on both sides of the Pacific., Raised a tens-of-millions-of-dollars Series A led by OrbiMed in 2022., Completed three CRO acquisitions in under four years: PharmaSols (2021), Courante Oncology, and DeltaMed Solutions (2024).

## Products & services

- **Clinical Data Science** — Data management, biostatistics, statistical programming, and advanced clinical data science supporting complex, biomarker-driven programs.
- **Regulatory Affairs** — Global regulatory strategy, dossier preparation, and multi-regional submissions across US, EU and APAC markets.
- **Clinical Operations** — End-to-end project management, clinical monitoring, site selection and multinational trial coordination across all phases.
- **Pharmacovigilance & Medical Safety** — Drug safety, patient safety and medical monitoring services led by experienced medical safety officers.
- **Medical Writing & Medical Monitoring** — Protocol design, clinical documentation and medical oversight of ongoing studies.
- **Quality Assurance & Audit** — GCP compliance, audit-readiness and quality management across trials.
- **Functional Service Provider (FSP) model** — Flexible, embedded resourcing for sponsors needing specific functional capabilities.
- **Strategic & VC Consulting** — Advisory on geography selection, participant demographics, development pathways, plus connections to venture capital for biotech clients.

## Achievements

- Grew from founding in 2020 to operations across roughly ten countries on both sides of the Pacific.
- Raised a tens-of-millions-of-dollars Series A led by OrbiMed in 2022.
- Completed three CRO acquisitions in under four years: PharmaSols (2021), Courante Oncology, and DeltaMed Solutions (2024).
- Recognized as a Top CRO in APAC (Pharma Tech Outlook, 2022).
- Built deep oncology and rare/orphan disease capability spanning solid tumors and hematologic malignancies.

## Latest updates

- **2024-07** — Acquired US-based CRO DeltaMed Solutions, its third acquisition, expanding data management and biostatistics capability and its US footprint (Evercore advised).
- **2022-03** — Closed Series A financing led by OrbiMed with participation from Fontus Capital to fund overseas expansion and digital clinical research capabilities.
- **2021** — Acquired ANZ-based PharmaSols, adding rapid Phase I trial capacity; also acquired US-based Courante Oncology for oncology depth.

## Links

- Website: https://harvestiro.com
- LinkedIn: https://www.linkedin.com/company/harvest-integrated-research-organization

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Profile page: https://yespress.io/hiro-harvest-integrated-research-organization
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Last updated: 2026-07-20