HiRO – An Emerging Full-service Global CRO

How HiRO Helps?

HiRO is an emerging full-service global CRO that offers rapid, capital-efficient, and reliable clinical trial solutions to fit the specific needs of biotechs.? ?

Many biotechs and drug manufacturers are hindered by limited resources and expertise, struggling to meet the speed and cost of clinical trials required to bring their products to market on schedule or faster than the competition.?

HiRO delivers accelerated commercialization pathways to global biotech and pharma by providing innovative end-to-end clinical trial solutions.

HiRO's Global Reach and Vision

HiRO’s unique East-West geographical reach and global vision will enable it to continue being a leading CRO that supports biotechs of all sizes in reaping the benefits of having a Global Partner.

Our global team is dedicated to providing its sponsors with speedy and economical clinical trials through its project management, quality audits, and strategic planning services. We assist clients in opportunity assessment, funding, global clinical trial design and clinical development planning (CDP), and efficient implementation all the way through to commercial launch.

At HiRO, we are people-led, cost-effective, and strive to deliver quality solutions. We are committed to serving clients who wish to conduct clinical research and development in the US and Asia Pacific. It is critical for biotechs to fully understand complex global medical requirements and regulatory pathways – HiRO provides customized support at every step of the way.

With a strategic presence in diverse markets, including the US, Ireland, Mainland China, Taiwan, Japan, Korea, Malaysia, the Philippines, Australia, and New Zealand, HiRO facilitates biotech companies in expanding their global reach and accelerating the development of innovative treatments.

Addressing Key Pain Points for Biotechs

Challenges for many biotechs continue to be around speed, cost and patient recruitment – HiRO provides a solution to all of these.

Leveraging our one global team approach, experience and depth of local networks we can help rapidly deploy studies and manage complex changes during study execution. We focus on the delivery of high-quality and cost-effective global solutions to identify the right team, the right geographic region and the right sites to deliver successful trial outcomes.

HiRO's Approach to Patient Recruitment and Multi-Regional Clinical Trials

With HiRO, patient recruitment is the core driver of the planning stage of every clinical trial. The FDA seeks diversity in clinical trials, and relying solely on data from a single country is no longer considered ideal when seeking overseas regulatory approvals.?

Following recent high-profile FDA marketing application rejections, where the FDA ruled that overseas single-country trials did not meet its criteria regarding foreign data, there is an emerging trend for sponsors to implement multi-regional clinical trials over single-country trials.

HiRO accelerates decision-making for biotechs with the agility required to effectively traverse the ever-evolving drug development arena. We offer knowledge-based consulting from the beginning of the early stage to help sponsors find the best way to proceed. HiRO also provides awareness of the capital market to boost fundraising opportunities for relevant stakeholders.

Additionally, HiRO’s global reach across the Asia Pacific and the expansions to the US and EU enables us to be a reliable partner for biotechs and pharma firms seeking to establish a footprint in these regions and maximize their access to patients.

HiRO's Unique Approach and Service Offerings

“We are considered a boutique CRO. We cater to SMEs and multinational organizations seeking to do cross-border regulatory submissions/applications and clinical trials execution by providing knowledge-based consultations that offer real value,” says Karen Chu, CEO of HiRO.

HiRO offers a broader service model than the traditional “full service” project management and clinical trial monitoring provider.?

This is facilitated through HiRO’s proven approach that simplifies and accelerates trial processes through a network of top CRO executives and the adoption of innovative technologies. HiRO’s “one global team” model is driven by a dedicated team of experts committed to providing rapid, reliable, and cost-effective solutions.

Streamlining and Accelerating Trials

Recognizing the need to simplify and accelerate trials through our networks, partnerships and the adoption of new technologies, HiRO offers a wider service model than the more traditional “full service” project management and monitoring of clinical trials. Our unique approach provides our customers with a more comprehensive, flexible range of solutions.

By working collaboratively in the early development phase of a new product, HiRO supports biotechs in planning and opportunity assessment, funding, global clinical trial design and implementation, and commercial manufacturing.?

HiRO’s global team of experts has the experience, the ability and the local and global networks to support biotechs through their entire product journey, working together “hand in hand” every step of the way.

HiRO: The Right-Sized Global CRO Solution

HiRO is the new global CRO solution – “just the right size”. The global CRO market is currently dominated by a few very large global CROs. These larger organizations are often tied to concrete processes, sacrificing innovative problem-solving and customer service. The scale of these global giants simply does not match the size of the smaller biotechs they service.

HiRO’s smaller “one global team” model is driven by a dedicated team of experts committed to providing more rapid, flexible, cost-effective solutions. The HiRO team provide a more tailored experience with a high level of interaction and focus on each unique clinical trial. It’s our people deliver successful clinical trials.

With an average of over 20 years of industry experience across our team, our sponsors are working with some of the best in the industry. We offer cutting-edge training to our clincial research team, improving their productivity and enabling highly collaborative engagement with customer teams.

Streamlining the Start-Up Process

By partnering with sponsors earlier in the development phase, HiRO seeks to streamline the start-up process of every clinical trial.?

With HiRO, we believe that early planning and clinical trial strategies result in successful trials. When properly planned, many start-up activities can be run in parallel, resulting in accelerated start-up timeframes. Locally based ethics and regulatory specialists and dedicated local start-up teams ensure that timelines are condensed.

Our one global team approach means that we are experienced in working collaboratively across geographic locations seamlessly. Proven integrated processes, supported by leading technology, HiRO is the go-to partner for biotechs looking to accelerate their drug development and commercialization processes in the global market.