"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.
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, HiROSmall 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 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.
Data management, biostatistics and statistical programming for complex, biomarker-driven programs.
Global regulatory strategy, dossier preparation and multi-regional submissions across US, EU and APAC.
End-to-end project management, monitoring, site selection and multinational trial coordination.
Drug safety, patient safety and medical monitoring led by seasoned medical safety officers.
Protocol design, clinical documentation and medical oversight of ongoing studies.
GCP compliance, audit-readiness and quality management built into every trial.
Functional Service Provider engagements for sponsors needing embedded, specific capabilities.
Guidance on geography, demographics and pathways - plus connections to venture capital.
Specialized support for cell & gene therapy, radiopharmaceuticals and orphan indications.
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:
Fig. 2 - Illustrative emphasis across HiRO's therapeutic practice, based on publicly stated specialties. Not a formal revenue split.
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.
Karen Chu establishes Harvest Integrated Research Organization as a globally oriented, integrated CRO for biotech.
Acquires ANZ-based PharmaSols for rapid Phase I capacity and US-based Courante Oncology for oncology depth.
Closes a tens-of-millions-of-dollars round (OrbiMed with Fontus Capital) to fund overseas expansion and digital clinical research capabilities.
Third CRO acquisition adds New Jersey-based data management and biostatistics strength; Evercore advised.
Operations span the US, Ireland, China, Taiwan, Australia, New Zealand, Japan, South Korea, Malaysia and the Philippines.
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.
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 profileBefore 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.