BREAKING HiRO closes Series A led by OrbiMed EXPANSION Third CRO acquisition: DeltaMed Solutions joins the network FOOTPRINT Operations across 10 countries on both sides of the Pacific FOCUS Oncology & rare disease trials that cross borders STRATEGY "As global as possible" - without becoming IQVIA FOUNDED 2020 by Karen Chu, veteran of 600-800 trials a year
HiRO - Harvest Integrated Research Organization logo
Fig. 1 - The HiRO wordmark. A CRO that calls the "I" integrated, not contract.
Company Profile — Clinical Research Organization

HiRO
Harvest Integrated
Research Organization

"The Modern CRO" - a mid-sized, integrated research organization built to run clinical trials across borders, connecting Asian science to Western capital and back again.

Founded 2020 OrbiMed-backed ~110 people 10-country footprint Oncology & Rare Disease
2020
Year Founded
3
CRO Acquisitions
~$20M
Series A (OrbiMed)
10
Countries Active

What HiRO Does

HiRO - short for Harvest Integrated Research Organization - is a full-service clinical research organization. Put plainly, it is the company a biotech hires when it has a promising drug and needs to prove that the drug works, safely, in front of regulators. That proof comes from clinical trials, and clinical trials are famously hard to run: patients in multiple countries, regulators with different rules, data that has to survive an audit years later.

What sets HiRO apart begins with a single letter. Most peers are contract research organizations. HiRO calls itself an integrated one. In practice that means it does more than execute a protocol handed to it - it helps design the development strategy, selects and manages a stable of pre-vetted vendors so the sponsor doesn't have to, and even connects clients to venture capital. The company describes the goal as combining agility with rigor.

The business was built for a specific customer the giants tend to overlook: the small, capital-constrained biotech. Founder Karen Chu spent two decades inside a mega-CRO before concluding that those companies were optimized for Big Pharma, leaving smaller innovators treated like minor accounts. HiRO's answer was to stay deliberately mid-sized while stretching its geography as far as possible - a bridge between Asian biotechs going west and Western sponsors coming east.

Our aim is not to become as large as the IQVIAs or Parexels of this world, but to remain a mid-sized CRO that is as global as possible.

Karen Chu — Founder & CEO, HiRO

Who It Serves & What It Solves

THE CUSTOMER

Resource-constrained biotech

Small and mid-sized biotech and pharmaceutical companies - especially Asian biotechs seeking to run trials in the US and Europe, and US/European sponsors wanting to conduct research in Asia. These are innovators with promising molecules and limited runway, who need a partner that understands both the science and the shortage of capital.

THE PROBLEM

Cross-border coordination

The hard part of a trial usually isn't the science - it's the coordination. Regulatory filings in several countries, pharmacovigilance across time zones, audit-ready data, and a chain of independent vendors each with their own contract. HiRO collapses that fragmentation into one integrated team spanning preclinical strategy through regulatory submission.

Products & Services

CORE

Clinical Data Science

Data management, biostatistics and statistical programming for complex, biomarker-driven programs.

CORE

Regulatory Affairs

Global regulatory strategy, dossier preparation and multi-regional submissions across US, EU and APAC.

CORE

Clinical Operations

End-to-end project management, monitoring, site selection and multinational trial coordination.

SAFETY

Pharmacovigilance

Drug safety, patient safety and medical monitoring led by seasoned medical safety officers.

DOCS

Medical Writing & Monitoring

Protocol design, clinical documentation and medical oversight of ongoing studies.

QUALITY

Quality Assurance & Audit

GCP compliance, audit-readiness and quality management built into every trial.

FLEXIBLE

FSP Model

Functional Service Provider engagements for sponsors needing embedded, specific capabilities.

ADVISORY

Strategic & VC Consulting

Guidance on geography, demographics and pathways - plus connections to venture capital.

MODALITIES

Advanced Therapies

Specialized support for cell & gene therapy, radiopharmaceuticals and orphan indications.

Where the Expertise Runs Deep

HiRO concentrates on the therapeutic areas that are hardest to commoditize - the trials with scattered patients, unfamiliar indications and multi-regional recruitment. The relative emphasis across its practice looks roughly like this:

Oncology
Solid tumors & heme
Rare / Orphan
Multi-regional
CNS
Dermatology
Metabolic
Cell & Gene / Radiopharm
Emerging

Fig. 2 - Illustrative emphasis across HiRO's therapeutic practice, based on publicly stated specialties. Not a formal revenue split.

How It's Different & Where It Fits

The global CRO market is dominated by names built for scale - IQVIA, Parexel, ICON, Fortrea, PPD. They are enormous, capable, and largely oriented around the biggest pharmaceutical sponsors. HiRO has chosen not to compete on their terms. Its differentiation rests on three deliberate choices: stay mid-sized, stay integrated, and stay genuinely local in each market it enters.

Being integrated means a sponsor deals with one partner and one contract rather than stitching together a dozen vendors. Being genuinely local means real offices and real regulator relationships in each country - the difference between promising global reach and actually holding the keys to ten front doors. And staying mid-sized means a small biotech is a priority client, not a rounding error.

Where HiRO fits in the market, then, is the cross-border lane between Asia and the West - a corridor of growing biotech activity that the mega-CROs serve but don't specialize in. By pairing trial execution with strategic consulting and even investor introductions, HiRO addresses the biotech customer's whole problem, not just the slice inside a standard statement of work.

That positioning is also its business model: fee-for-service clinical development contracts, flexible FSP engagements, and strategic consulting, with growth accelerated by acquiring regional CROs to add capability and geography. Three acquisitions in roughly four years turned a 2020 startup into a company operating across ten countries.

Global Footprint

United States Ireland Mainland China Taiwan Australia New Zealand Japan South Korea Malaysia Philippines

The Story So Far

2020

HiRO is founded

Karen Chu establishes Harvest Integrated Research Organization as a globally oriented, integrated CRO for biotech.

2021

First two acquisitions

Acquires ANZ-based PharmaSols for rapid Phase I capacity and US-based Courante Oncology for oncology depth.

2022

Series A led by OrbiMed

Closes a tens-of-millions-of-dollars round (OrbiMed with Fontus Capital) to fund overseas expansion and digital clinical research capabilities.

2024

DeltaMed Solutions joins

Third CRO acquisition adds New Jersey-based data management and biostatistics strength; Evercore advised.

2025

Ten-country network

Operations span the US, Ireland, China, Taiwan, Australia, New Zealand, Japan, South Korea, Malaysia and the Philippines.

Funding & Leadership

SERIES A — MARCH 2022

Tens of millions, led by OrbiMed

HiRO's Series A was led by healthcare investor OrbiMed with participation from existing shareholder Fontus Capital (reported at roughly $20M). Proceeds funded overseas market entry, talent, and digital clinical research management.

AT THE HELM

Karen Chu, Founder & CEO

Chu brings 20+ years of CRO management. Before HiRO she supervised an estimated 600-800 trials annually and managed thousands of professionals across dozens of countries - experience that shaped her thesis that smaller biotechs deserve a different kind of partner.

HiRO positions itself as an integrated rather than a contract research organization - comprehensive support that goes beyond traditional CRO services.

From HiRO's company profile

Worth Knowing

Before founding HiRO, Karen Chu oversaw an estimated 600-800 clinical trials a year and managed 5,700+ professionals across 55 countries.

HiRO deliberately does not want to become as big as IQVIA or Parexel - its stated goal is to stay mid-sized but maximally global.

The company built most of its global map by acquisition: three CROs across three continents in about four years.

Unusual for a CRO, HiRO also connects its biotech clients to venture capital - part service provider, part matchmaker.

Frequently Asked

What does HiRO do?
HiRO is a full-service clinical research organization (CRO) that helps biotech and pharma companies plan and run clinical trials across borders - from preclinical strategy through regulatory submission.
What does the "I" in HiRO stand for?
Integrated. HiRO calls itself an "integrated" research organization rather than a traditional "contract" one, adding strategic consulting and vetted-vendor management on top of trial execution.
Who founded HiRO and when?
Karen Chu founded HiRO in 2020. She previously oversaw hundreds of trials a year and thousands of staff across dozens of countries at a large CRO.
Who invested in HiRO?
HiRO raised a tens-of-millions-of-dollars Series A in March 2022 led by OrbiMed, with participation from existing shareholder Fontus Capital.
What are HiRO's therapeutic specialties?
HiRO focuses on oncology and rare/orphan disease, with additional expertise in CNS, dermatology and metabolic indications, plus advanced modalities like cell & gene therapy and radiopharmaceuticals.

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