Part 1 of 5 in our series: What Makes a Modern CRO?
Inside HiRO’s Global Growth Story
Why today’s biotech companies need strategic guidance, operational excellence, and true development partnership beyond traditional outsourcing.
The term “CRO” means different things to different sponsors. For some, it’s a vendor that runs trial logistics. For others, it’s a strategic partner embedded in every major development decision. So, what actually separates the two?
According to HiRO Founder and CEO Karen Chu, that gap is exactly what distinguishes a legacy CRO from what she calls a modern global CRO. And as the clinical development landscape grows more fragmented and competitive, that distinction matters more than ever.
From Startup to 500 People Across Four Continents
HiRO’s growth over the past five years has been substantial. The company now operates with roughly 500 people across the United States, Canada, Europe, ANZ, and the Asia-Pacific region. But headcount and geography only tell part of the story. The more interesting shift is in what sponsors are actually asking HiRO to do.
To learn more about HiRO’s team and mission, visit our About Us page.
Today’s biotech companies are operating leaner than ever, and that changes what they need from a CRO. Executing a trial protocol well is no longer enough. Instead, sponsors need a partner who can help shape development strategy itself: regulatory planning, country selection, and the sequencing of a compound’s entire clinical pathway.
What Makes a CRO “Modern”
So, what actually makes a CRO modern in this environment? For HiRO, it starts with understanding the pressures biotechs face today: the need to generate meaningful data quickly, the requirement to stay capital efficient, and the challenge of navigating a regulatory landscape that shifts by geography and therapeutic area.
Because of these pressures, a modern CRO’s job is as much about closing knowledge gaps as it is about operational execution. That means analyzing how regulators in a given market are likely to view a dataset, weighing the comparative advantages of different trial locations, and helping sponsors anticipate downstream considerations like reimbursement and market access, long before a trial ever reads out.
Layer proprietary technology on top of that consultative approach, technology designed specifically to reduce cost and compress timelines, and you get much closer to what a modern CRO needs to be.
A Client Base That’s Evolving in Real Time
HiRO’s client roster today splits roughly evenly, by revenue, between biotech companies and multinational pharmaceutical organizations. However, the biotech segment is growing faster. Many of these relationships start early, often at Phase I, and HiRO stays involved as programs progress through Phase II and III. In some cases, HiRO even follows an asset through a licensing transaction to its new owner.
That longevity matters because what a sponsor needs from a CRO changes as a program matures. Early-stage studies tend to be single-country and heavily focused on speed and cost efficiency. As programs advance, though, sponsors increasingly need multi-country execution paired with genuine strategic input on how to generate the data required to keep moving forward. This dynamic is accelerating as more Chinese biotech companies push compounds into later-stage global development.
Why a Modern CRO Matters for Sponsors
If you’re a biotech leader evaluating CRO partners, here’s the practical takeaway: don’t judge the right partner only on execution capability at your current phase. Instead, ask how they think about the phase after that, and the one after that.
A CRO that grows its involvement alongside your program, rather than resetting the relationship at every phase transition, is the kind of modern CRO that can actually compound in value over the life of an asset.
