Harvest Integrated Research Organization

What Harvest Integrated Research Organization does

Harvest Integrated Research Organization (HiRO) is a privately held, full-service global Contract Research Organization (CRO) that delivers end-to-end clinical development services to biotechnology and pharmaceutical sponsors across four regions (U.S., Europe, APAC, ANZ). Founded in 2020 and headquartered in Somerset, New Jersey, the company operates through 12+ offices spanning the United States, Australia, New Zealand, Japan, China (Shanghai and Beijing), South Korea, Taiwan, Malaysia, the United Kingdom, and Romania. HiRO's service portfolio spans seven core modules (Clinical Data Science, Clinical Operations, Regulatory Affairs, Medical Writing, Medical Monitoring, Pharmacovigilance, and Quality Assurance) supplemented by a Functional Service Provider (FSP) model for embedded resourcing, and covers therapeutic areas including oncology, rare diseases, CNS, dermatology, metabolic disorders, and healthy volunteer studies, with specialized capabilities in radiopharmaceutical and cell/gene therapy modalities.

The company's core technology platform is the proprietary HiRO Linkage™ operating framework, which connects people, systems, processes, oversight, data, and collaboration into a unified global execution model across regions. This is augmented by Foresight™, a real-time clinical data environment that consolidates raw, external, and derived clinical data into a single platform for faster interim analyses. The technology ecosystem also includes standard EDC (Electronic Data Capture), CTMS (Clinical Trial Management System), and Risk-Based Quality Management (RBQM) analytics for centralized monitoring and automated risk detection. CDISC standards compliance and statistical programming capabilities support submission-ready data outputs. The company reports a cumulative track record of 1,500+ studies conducted globally, including 402 oncology trials, 224+ rare disease studies, and 163 CNS studies, with 76K+ oncology patients and 20K+ advanced therapy patients enrolled.

HiRO generates revenue through project-based professional services contracts (full-service CRO engagements) and managed-services arrangements (FSP model) priced via RFP processes. Pricing is quote-based, varying by study scope, therapeutic area, phase, regions involved, and service model, and is not publicly disclosed. Customer segments are predominantly biotech sponsors (with anonymized case-study clients ranging from early-stage startups to mid-cap biotechs) and pharmaceutical sponsors, alongside a smaller medical device sponsor segment. The company has raised tens of millions of dollars in a Series A round led by OrbiMed in March 2022 (with participation from FC Capital, New Alliance Capital, and Panacea Venture), and has executed three acquisitions: PharmaSols (November 2021, ANZ-focused CRO), Courante Oncology (August 2023, oncology-specialist CRO), and DeltaMed Solutions (July 2024). Go-to-market is consultative enterprise sales, executed primarily through major industry conferences (J.P. Morgan Healthcare Conference, BIO International/Asia, ASCO, DIA, ARCS) supplemented by content marketing, case studies, and direct RFP engagement.

Name

Harvest Integrated Research Organization

Legal name

Harvest Integrated Research Organization

Website

https://harvestiro.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

101–250 employees

Short description

Harvest Integrated Research Organization (HiRO) is a privately held, full-service global Contract Research Organization delivering end-to-end clinical trial services to biotech and pharmaceutical sponsors across the U.S., Europe, APAC, and ANZ through 12+ offices and its proprietary HiRO Linkage™ and Foresight™ platforms.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Functional Service Providers (FSP) & Resourcing CROs (HLAGAAAM), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI)

Keywords

• Clinical research services
• Contract research organization
• Clinical trial management
• Biopharmaceutical development
• Regulatory affairs services

Headquarters

HQ city

Excelsior

HQ country

United States

HQ region

North America

Offices12 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Full-Service CRO Contracts: HiRO delivers end-to-end clinical trial services as a full-service global CRO. Sponsors engage HiRO to manage complete clinical programs from startup through submission, spanning all phases (I–IV) and therapeutic areas. Revenue is generated through project-based contractual agreements with biotech and pharmaceutical sponsors.
2. Functional Service Provider (FSP) Model: HiRO offers flexible FSP services where dedicated teams (Clinical Data Science, Pharmacovigilance, Medical Monitoring) integrate into sponsor workflows on a functional basis. This model provides predictable, scalable resourcing aligned to specific program needs, generating recurring revenue from long-term functional support engagements.
3. Standalone/Discrete Service Engagements: HiRO provides standalone services tailored to specific program needs, including regulatory affairs consulting, quality assurance, medical writing, and pharmacovigilance. Sponsors can engage for targeted expertise on a project basis.

Go-to-market motion3 records

Distribution channels1 record

Marketing channels7 records

Core offering

HiRO is a full-service global Contract Research Organization (CRO) delivering end-to-end clinical development services for biotech and pharmaceutical sponsors across all phases (I-IV). Its service portfolio includes seven core modules: Clinical Data Science, Clinical Operations, Regulatory Affairs, Medical Writing, Medical Monitoring, Pharmacovigilance, and Quality Assurance, offered through full-service or Functional Service Provider (FSP) engagement models. The company operates a proprietary unified global operating model called HiRO Linkage™ and an exclusive real-time data platform called Foresight™.

Product overview

Harvest Integrated Research Organization (HiRO) operates as a full-service global Contract Research Organization (CRO) offering end-to-end clinical development services through a unified operating model called HiRO Linkage™. The portfolio consists of seven core service modules—Clinical Data Science, Clinical Operations, Regulatory Affairs, Medical Writing, Medical Monitoring, Pharmacovigilance, and Quality Assurance—supplemented by a Flexible Service Provider (FSP) model for targeted functional support. Therapeutic expertise spans Oncology, Rare Diseases, CNS, Dermatology, Metabolic disorders, and Healthy Volunteers, while specialized modality capabilities cover Radiopharmaceutical and Cell and Gene Therapy programs. The company delivers clinical trials across four regions (US, APAC, ANZ, and Europe) through integrated teams of 400+ professionals. Key technology features include Foresight™ Real-time Data for unified clinical data visibility.

Differentiator

Problem solved

Functional benefit

Brands

• HiRO LINKAGE™: A unified global operating model built to give biotechs clarity, predictability, and speed—the pillars needed for a successful study. Focus areas include People, Systems, Processes, Oversight, Data, and Collaboration.
• Foresight™ Real-time Data

Products and services

• Clinical Operations

Quantifiable outcome

• 40 days from final protocol receipt to full regulatory approval for Phase I dermatology study (UK biotech)
• +10 more outcomes

Named customers7 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators24 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• IQVIA: IQVIA is the largest global full-service CRO and clinical technology provider, offering end-to-end Phase I-IV services across all therapeutic areas. It is comparable as a broad incumbent competing in the same full-service CRO market as HiRO, but at vastly greater scale and breadth.
• ICON plc: ICON is a top-3 global CRO offering full-service and FSP models across all phases and therapeutic areas. It is a broad incumbent peer serving the same biotech and pharma sponsor base as HiRO, with significantly larger scale post-PRA Health Sciences merger.
• Labcorp (Covance Drug Development): Labcorp's Covance division is a leading global CRO providing full-service clinical development and central laboratory services. It competes in the same full-service CRO market as HiRO but with deeper central lab integration and broader service portfolio.
• Parexel International: Parexel is a global CRO offering full-service clinical development, FSP, and regulatory consulting to biotech and pharma. It is a broad incumbent peer serving similar sponsor segments as HiRO, with greater scale and an established global footprint.
• WuXi AppTec: WuXi AppTec is a China-headquartered global CRO/CDMO offering clinical trial services alongside broader discovery and manufacturing capabilities. It is a broad incumbent peer given overlapping China roots and clinical CRO services, though now constrained by US BIOSECURE legislation.
• Charles River Laboratories: Charles River provides preclinical and clinical research services to biotech and pharma, with a clinical division serving Phase I-IV trials. It is a broad incumbent peer serving overlapping sponsor segments as HiRO, with deeper preclinical and safety assessment capabilities.

Direct peers

• Medpace: Medpace is a mid-sized full-service CRO focused primarily on small and mid-cap biotech sponsors across multiple therapeutic areas. It is a direct peer to HiRO given overlapping biotech-centric GTM, full-service model, and similar mid-cap positioning, though Medpace is much larger and US-centric.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized global CRO specializing in complex therapeutic areas including CNS, oncology, and rare diseases. It is a direct peer to HiRO given comparable therapeutic focus areas, biotech sponsor base, and mid-cap positioning.
• Tigermed: Tigermed is a leading China-based clinical CRO offering full-service Phase I-IV trial services with growing international presence. It is a direct peer to HiRO given overlapping China-origin, full-service CRO model, and APAC-to-global expansion strategy.
• Novotech (Novotech Health Holdings): Novotech is an APAC-headquartered global CRO specializing in biotech clinical trials across oncology and rare diseases with strong US and ANZ presence. It is a direct peer to HiRO given comparable APAC origins, biotech focus, oncology/rare disease expertise, and mid-cap cross-border positioning.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/harvest-integrated-research-organization

Revenue estimate

Valuation estimate

Number of profiles

Profiles19 records

Subsidiaries1 record

Funding overview

Funding rounds1 record

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A3 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Harvest Integrated Research Organization