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Karen Chu, CEOHarvest Integrated Research Organization (HiRO), a clinical research organization (CRO) dedicated to providing its sponsors with speedy and economical clinical trials through its project management, quality audits, and strategic planning services. It assists clients in opportunity assessment, funding, global clinical trial design and clinical development planning (CDP), efficient implementation, all the way through to commercial launch.
Transforming Trial Management through Expertise-Based and Client-friendly Services
Typically, biotech companies understand the hurdles that limited resources can bring to their drug discovery and clinical trials operations. HiRO accelerates decision-making for such companies with the agility required to effectively traverse the ever-evolving drug development arena. It offers knowledge-based consulting, from the beginning of early stage to help sponsors find the best way to proceed. HiRO also provides awareness on the capital market to boost fundraising opportunities for relevant stakeholders.
“We are considered a boutique CRO. We cater to SMBs 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.
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We offer cutting-edge training to our clinical research team, improving their productivity, and enabling highly collaborative engagement with customer’s teams
A Holistic and Tech-Driven Client Engagement Approach
HiRO begins every client engagement by engaging with the firms at the discovery stage, assisting in the in-depth evaluation of assets and datasets, and offering strategic development consultancy. By supporting the execution of early-stage tasks, the company boosts efficiencies throughout the overall drug development cycle and improves go-to-market time.
HiRO fulfills its goals by relying on its experienced management team that boosts the day-to-day operations by acting as executives and sponsors to oversight the quality of projects. At the same time, it offers cutting-edge trainings to its clinical research team, improving their productivity and enabling highly collaborative engagement with customer’ teams.
HiRO categorizes biotechs into different groups and addresses their distinct needs in a highly intuitive manner. The first category includes startups and smaller firms where most clients are at the preclinical stage, perfectly poised for HiRO to unlock efficiencies through its consultant expertise. For startups, it reviews the chemistry, manufacturing, and controls (CMC) of clinical trials, along with their protocol, and performs robust strategy development to help them choose the country best suited for their first in human study. With a host of such complete offerings in a single package, HiRO ensures a fast and cost-efficient way of achieving the groundwork as it increases the company’s current and future compound value.

HiRO’s “one global team” model is driven by a dedicated team of experts committed to providing rapid, reliable, and cost-effective solutions. The team facilitates a tailored-made client experience with a high level of interaction. It leverages its flexibility and agility to help biotechs manage various international requirements and regulations avoiding conventional hurdles. Through its vast experience and collaborative approach, with local and global partners working hand-in-hand with clients, HiRO supports biotechs in navigating the complex journey from laboratory to NDA/or commercialization.

Concurrently, HiRO’s global reach across China, the U.S., and Europe enables it to be a reliable partner for biotechs and pharma firms seeking to establish a footprint in these regions and maximize its access to patients. Within China, where new, streamlined and accelerated clinical processes are significantly trying to reduce start-up timelines, HiRO is supporting local and multinational organizations in capitalizing on these rising opportunities.
The global biopharmaceutical market is positioned to witness rapid growth powered by evolving technology and innovation, favorable government policy changes/reform/or upgrade, and increasing investment in research and development (R&D). With such prospects on the horizon, 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.
Company
HiRO
Management
Karen Chu, CEO
Description
Harvest Integrated Research Organization (HiRO) is a China-based globally oriented clinical research organization (CRO). With global operations and integrated capabilities, the company provides its clients with a full range of solutions and services, and strives to become a market-leading, global CRO that works conjunction with biotech and pharmaceutical companies to bring new products from the laboratory to market.
Following the acquisitions of ANZ-based PharmaSols in 2021 and US-based Courante Oncology last year, HiRO's global expansion continues with the integration of DeltaMed Solutions. With its established footprint in the US, Ireland, Mainland China, Taiwan, Australia, New Zealand, Japan, South Korea, Malaysia, and the Philippines, HiRO solidifies its position as a comprehensive provider of end-to-end clinical research solutions on a global scale.
DeltaMed Solutions, headquartered in New Jersey, boasts a team of highly skilled industry professionals with 15-30 years of expertise in serving large to mid-sized pharmaceutical and biotechs. The leadership team also brings a wealth of experience in FDA and EMEA submissions. DeltaMed Solutions is widely recognized for its extensive experience and flexible service models in data management, biostatistics, programming, RWE solutions, PK/PD analysis, regulatory and medical affairs. The company has earned recognition from clients and partners for its outstanding track record of excellence and service quality.
The full integration of DeltaMed Solutions into HiRO's operations will foster a powerful alliance, leveraging the expertise of both companies in key therapeutic areas and service offerings. This broadens HiRO's network of clients and partners, and enhances its ability to deliver capital-efficient, expedited, and customized clinical trial solutions, addressing the unmet R&D needs of pharmaceutical and biotech companies worldwide.
Dr. Karen Chu, Founder and CEO of HiRO, expressed her confidence in the acquisition, stating, "We are delighted to extend a warm welcome to DeltaMed Solutions. This acquisition aligns seamlessly with HiRO's growth strategy, enhancing our capability to continue delivering exceptional services that exceed industry standards. By combining our resources and expertise, we are strongly positioned to become our clients' trusted partner in advancing patient treatments and making a lasting impact on the healthcare landscape. This collaboration leverages our collective strengths, ensuring optimal efficiency and effectiveness in conducting clinical trials across a wide range of therapeutic areas in the US, Asia-Pacific, and beyond. This sets us apart as a pioneering force in the highly competitive CRO industry."
Dr. Sam Liang, President of DeltaMed Solutions, added, "We are thrilled to become an integral part of HiRO and contribute to their continued success. This opportunity allows us to harness our scientific expertise and well-established presence in the US. Working together, we will offer an enriched, globally integrated suite of services to our clients, driven by our shared dedication to quality, innovation, and patient-centric research. This collaboration will streamline processes and accelerate the development of groundbreaking treatments."
With this strategic acquisition, HiRO and DeltaMed Solutions join forces to provide an unparalleled range of services, delivering bespoke and efficient clinical trial solutions that effectively navigate market-specific complexities globally. Their shared vision and commitment to excellence in clinical research uniquely position them as key contributors to advancements in healthcare and pharmaceutical innovation.