As the global clinical development landscape becomes more fragmented and competitive, biotechs increasingly need partners that can help them navigate regulatory complexity, identify the right trial locations, and generate meaningful data quickly. In this context, Harvest Integrated Research Organization has been expanding its international footprint while positioning itself as a more integrated and strategic partner for emerging innovators. CEO Karen Chu reflects on the evolution of the organisation, the shifting role of Asia in global trials, and the growing importance of technology and regulatory insight in modern drug development.
How has HiRO evolved since our last conversation in 2023, and how do you define the concept of a “modern global CRO”?
Since 2023, we have continued to expand both our geographic footprint and our capabilities. Today we are around 400 people globally, with operations across the United States, Canada, and the Asia-Pacific region, and a growing presence in Europe that we expect to formalise shortly. When we speak about a “modern global CRO,” we are referring to a partner that goes beyond simply executing clinical trials. Many biotech companies now operate with limited resources and face increasing pressure to move quickly while remaining capital efficient, which means they require support not only in running trials but also in shaping broader development strategies, including regulatory planning, country selection, and overall clinical development pathways.
From our perspective, the concept of a modern CRO begins with understanding what modern biotech companies actually need in today’s environment. The global landscape has become more complex and uncertain, and sponsors must generate meaningful data as quickly as possible while navigating regulatory expectations and increasingly competitive trial locations. In that context, our role is to help close the knowledge gap by analysing how regulators are thinking, assessing the comparative advantages of different countries, and helping sponsors anticipate downstream considerations such as reimbursement and market access. This consultative approach, combined with proprietary technologies designed to reduce costs and accelerate operational timelines, is how we define a modern CRO responding to the realities of drug development today.
How do you approach acquisitions at HiRO, and what capabilities do you prioritise when integrating new organisations into your global platform?
Because HiRO started from scratch about six years ago, acquisitions have been an important way for us to build both our geographic reach and our capabilities. We focus first on organisations that complement what we already do, either through specialised expertise or a strong regional footprint, and we look for teams that have already developed a competitive advantage in their markets. A good example is our Australia and New Zealand team, which joined HiRO through the acquisition of PharmaSols. They bring more than two decades of experience running clinical trials across the region. While Australia has long been a well-established destination for early-phase studies, New Zealand is increasingly emerging as an attractive alternative, offering strong patient access and less competition for recruitment. That combination allows us to offer sponsors greater flexibility in trial design and patient recruitment strategies. Other acquisitions have strengthened areas such as data science, expanding our analytical capabilities while also bringing relationships with multinational pharmaceutical companies. This not only deepens our technical expertise but also creates opportunities to broaden our service offering and accelerate our entry into new markets.
What does HiRO’s client base look like today, and how are their expectations evolving as programmes move through development?
From a financial perspective, our client base today is roughly evenly split between biotech companies and multinational pharmaceutical organisations, although the biotech segment is growing rapidly. Many of these companies begin working with us at the earliest stages of development, often in Phase I, and we continue supporting them as their programmes progress through Phase II and Phase III. In many cases, we effectively follow the compound throughout its development journey, and sometimes even beyond licensing agreements when assets change hands.
As those programmes advance, the expectations placed on a CRO naturally evolve. Early-stage studies are often conducted in a single country and focus heavily on speed, quality, and cost efficiency. As sponsors move into later phases, however, they require broader multi-country studies and a more strategic perspective on how to generate the right data to move forward. Our role therefore grows alongside our clients, combining operational execution with strategic guidance while navigating a rapidly evolving landscape, particularly as more Chinese biotech companies begin advancing their compounds into later-stage development.
How are global regulators such as FDA and EMA approaching the growing volume of clinical trial data generated in Asia?
From our experience, regulators such as the FDA and EMA remain fundamentally science driven in how they assess clinical data generated outside their own regions. Their evaluation typically revolves around a few key considerations. First, they examine whether there are intrinsic or extrinsic ethnic factors that could influence how a drug performs across different populations, including biological differences, variations in medical practice, or differences in standards of care. Second, they look closely at whether the treatment landscape in the trial setting is comparable to that of the markets where approval is being sought, particularly in terms of treatment pathways such as first-, second-, or third-line therapies.
A third aspect concerns patient diversity. While regulators in the United States increasingly emphasise the importance of enrolling more diverse patient populations, the same logic also applies in reverse when assessing datasets that are heavily concentrated in a single ethnic group. In those situations, regulators will naturally examine how broadly the findings can be generalised. Overall, the process remains rooted in scientific justification rather than geography. It is rarely a simple yes or no decision; rather, regulators increasingly expect a clear explanation demonstrating why the data should be considered applicable across populations.
How are regulatory developments across Asia influencing clinical trial strategy, and how does HiRO help sponsors navigate these evolving frameworks?
Regulatory frameworks across Asia, particularly in China, are evolving rapidly, but the direction of travel is usually communicated well in advance. Authorities often signal their intentions many months before new policies take effect, which allows organisations like ours to anticipate changes and work with clients to prepare accordingly. One example is China’s Decree No. 828, which strengthens lifecycle oversight under the country’s Drug Administration Law and places greater responsibility on sponsors for safety, quality, and compliance from early development through to commercialisation. Developments such as these require us to adapt the way we support sponsors, particularly in areas such as cell and gene therapy where regulatory expectations may differ from traditional clinical development models.
Beyond China, several markets across Asia are becoming increasingly relevant for global clinical programmes. Japan, historically seen as expensive and operationally demanding, has become more competitive in recent years while maintaining a reputation for high-quality clinical execution and reliable patient recruitment. South Korea continues to perform strongly in certain therapeutic areas, particularly gastrointestinal cancers, while Taiwan region is working to improve trial efficiency by aligning hospital systems and streamlining processes such as site contracting. Across Southeast Asia, countries such as the Philippines and Malaysia are also emerging as valuable locations for specific indications, including vaccine studies. Together with established early-phase hubs such as Australia and New Zealand, these developments are expanding the range of options available to sponsors designing global clinical development strategies.
How are geopolitical dynamics and tightening data governance rules affecting global clinical research operations?
Geopolitical developments and increasing scrutiny around data governance are certainly adding new layers of complexity to global clinical research. Much of the discussion today centres on how clinical and patient data are stored, protected, and transferred across jurisdictions. In our case, for example, we operate separate data environments in China and in the United States, with appropriate safeguards in place between them, reflecting the different regulatory requirements that apply in each market. China has introduced stringent data privacy and cybersecurity regulations, which require companies to take additional steps when handling health data or transferring information internationally. Similar developments can also be seen across other jurisdictions as data governance requirements continue to evolve. For sponsors conducting trials across borders, this means navigating more procedural requirements and ensuring that their data infrastructure is structured carefully to remain compliant with local regulations.
At the same time, this complexity is becoming part of the reality of running global development programmes. Biotech and pharmaceutical companies must recognise that as the regulatory environment evolves, additional safeguards and compliance processes will inevitably follow. While this creates more steps in the operational process, it can also serve as a form of risk management. Operating in multiple regions exposes companies to different regulatory frameworks, but it also reduces the reliance on any single jurisdiction and allows sponsors to balance opportunities and constraints across global markets.
How is HiRO incorporating AI and automation into its operations and how are these technologies shaping your ability to support increasingly complex therapeutic modalities?
Artificial intelligence and automation are gradually being introduced across many aspects of our operations, although the applications vary depending on the function. One visible example is how we manage and deliver clinical trial data. Instead of relying solely on periodic reports, sponsors can access real-time study information through digital dashboards that present the data in formats that are immediately useful, such as graphs, tables, and visual summaries. Automation is also being applied in areas such as medical writing and pharmacovigilance, where software can assist with generating draft clinical documents or processing safety data more efficiently. The intention is not to replace human judgement but to reduce the manual workload associated with routine tasks, allowing our teams to focus more on interpretation, analysis, and decision-making.
Over time, we expect this to evolve beyond individual task automation into a more integrated, company-wide approach in which operational data can feed into systems that help us work faster and more effectively. At the same time, advances in therapeutic innovation, particularly in areas such as cell and gene therapy, are also shaping how we adapt our capabilities. These programmes often require more specialised trial designs and operational precision, and we are learning alongside our clients as new modalities such as gene editing continue to emerge. In China especially, regulatory developments and increasing readiness within hospital systems suggest that this field could progress very rapidly over the coming years.
Looking ahead, what are HiRO’s priorities for the next phase of its development, and what continues to motivate you personally as you lead the organisation forward?
As we look to the future, our focus is increasingly on the areas where human expertise remains indispensable. Clinical research is still a highly labour-intensive industry, and while artificial intelligence will inevitably replace some operational tasks, many of the most important aspects of our work cannot be automated. Building trusted relationships with hospitals and investigators, navigating complex regulatory environments, addressing unexpected challenges during clinical programmes, and managing the realities of a rapidly shifting geopolitical landscape all require judgement, experience, and close collaboration. These are precisely the areas where we believe organisations like HiRO can continue to make the greatest contribution. In many ways, our internal philosophy is quite simple: if a task can eventually be handled entirely by AI, then it is probably not where we should focus our efforts. Our role is to concentrate on solving the more complex problems that still require human insight and coordination.
On a personal level, what continues to motivate me is seeing the tangible impact that new therapies can have on patients’ lives. Occasionally we hear stories that remind us why this work matters so much. I remember one patient who was able to return to work only a week after receiving treatment through a clinical programme, something that had previously been impossible. Experiences like that highlight how much progress the field is making. Increasingly, new medicines are not simply extending life by a few months but offering long-term improvements and, in some cases, genuine cures. At the same time, there remains a great deal of unmet need. Friends and family often ask why certain diseases still have no treatment or why participation in clinical trials can be so difficult, and those questions serve as a constant reminder that there is still much work ahead. Knowing that the efforts of our teams and our partners can ultimately improve or even save lives is what continues to drive us forward.
What message would you like to share with potential clients and partners considering working with HiRO?
HiRO was built with a clear understanding of the realities many biotech companies face. A team may have a very promising therapy, yet still struggle with fundraising, strategic direction, or the complexity of navigating global clinical development. Our role is to help bridge that gap. We work closely with both established organisations and smaller biotech companies, knowing that some of the most innovative assets often come from teams that are still building their resources. One piece of feedback we hear frequently is that our leadership team remains closely involved, approaching each programme with a strong sense of ownership and treating every asset with the same care we would give our own. Clients often ask me directly, “If this were your product or your company, what would you do?” and those are the conversations that define the relationship we aim to build. Ultimately, we see ourselves as a partner that understands the pressures biotech companies face and works alongside them to help move their programmes forward.
