HiRO: Simplifying the Clinical Research Process

HiRO is a Clinical Research Organization that specialises in providing research services to the pharmaceutical, biotechnology, and medical device industries. Founded in 2020 by veterans of the CRO, biotechnology, and pharmaceutical industries, the company provides support for various stages of drug development, including preclinical and clinical research, regulatory affairs, and data management. The company is headed by CEO Karen Chu, who has 20+ years of relevant industrial experience in CRO management and operations, along with four years of experience as a partner at Fontus Capital. The company currently has regional offices based in Mainland China, the Philippines, Taiwan, Australia and New Zealand. 

Challenges identified by HiRO in the CRO industry:

In the words of the CEO of HiRO, Karen Chu, “The world needs more innovative medicines. In an increasingly complex global environment, biotech and pharma need greater support to accelerate the delivery of these new products to market.“ The company strives to solve the following problem faced by biotech companies.

1. Lack of access to expertise: Small and medium-sized companies do not have access to specialised knowledge in clinical trial design, implementation, and management, which is essential for developing new drugs and medical treatments. This expertise can be challenging to maintain in-house for some pharmaceutical companies, especially those that do not conduct clinical trials frequently.
2. Limited Resources: Inadequate resources like specialised equipment, facilities, and experienced personnel may prevent pharmaceutical companies from conducting high-quality clinical trials. This may discourage small companies from launching new products, as procuring resources to conduct research can be very expensive.
3. Risk Management: There are several risks associated with clinical trials, such as ensuring that tests are conducted in compliance with regulatory guidelines, the risk of delays or setbacks, patient safety risks, financial risks, and operational risks. For small companies, it is tough to conduct clinical trials by eliminating the associated risks.
4. Dominance of large CROs: “The global CRO market is currently dominated by a few very large global CROs. These larger organisations are often tied to concrete processes, sacrificing innovative problem-solving and customer service,” says Karen. These global companies do not cater well to the specific need of small companies.

Services offered by HiRO and how are they unique?

HiRO was incorporated to solve the problem faced by the growing global biotech industry in the complex business environment. The HiRO management team is driven by the desire to work closely with the clients and provide them with a customised solution that caters to their needs and helps them develop new products efficiently. HiRO provides a wide range of services to its clients, such as:

• Project Management: Project management services at HiRO refer to the range of activities and responsibilities involved in overseeing the planning, execution, and monitoring of clinical trials on behalf of sponsors. HiRO plays a crucial role in the drug development process by providing various project management services to pharmaceutical and biotechnology such as Project Planning, Portfolio and Product Development Strategy, Full Clinical Development Services, from Protocol Design to Clinical Report, and Risk Management.

The HiRO project management team has about on average16 years of relevant experience in leading biopharma and CRO companies. In addition to that, the company has exposure to managing large-scale global trials, including US IND studies and Japan plus Asia studies, which enables it to combine local experience and international standards.

• Clinical Science and Medical Affairs: Clinical Science and Medical Affairs are two critical functions within the pharmaceutical and biotechnology industries that work in parallel to advance the development and use of innovative therapies. HiRO provides a complete service that starts with medical monitoring and includes processes like pharmaco-vigilance, medical writing, consultation, and training.

The service provided by the company ensures patient safety, successful results, and compliance. Team members have about 15 years of experience across life science, academia, and clinical setting, which helps the company to deliver results with efficiency and accountability.

• Quality and Audit: HiRO provides quality and audit services to pharmaceutical and biotechnology companies to help them maintain quality, reduce risk, and ensure regulatory compliance. It allows companies to conduct clinical trials in compliance with applicable regulations, guidelines, and standard operating procedures.

Hiro is the designated provider of Risk-Based Quality Management (RBQM) expertise and technology in Greater China for CluePoints. It has helped companies to avoid and reduce risk while extracting critical data and has delivered high-quality projects on a timely basis.

• Clinical Operations: HiRO provides a wide range of services to support clinical trials, from study design and protocol development to site selection, patient recruitment, feasibility studies, and clinical monitoring. HiRO’s all the team members are former CRAs/CRCs/SSUs and thoroughly understand clinical trial procedures/requirements and how to communicate clinical sites.
• Data Operation: HiRO data operation services include a range of activities involved in managing and analysing clinical trial data. The company ensures that the data collected during a clinical trial is accurate, reliable, and complete for generating insights that can inform decisions about drug development.

HiRO’s flexible data science service uses a robust project management model, streamlined data management, biostatistics, and programming to yield the best results for clients.

What gives HiRO an edge over its competitors?

As HiRO operates in the service industry of the medical domain, its highly skilled and motivated workforce has helped the company to differentiate itself from competitors and improve customer satisfaction. With about 20 years of core experience in the industry, the team comprises people with the right skills, attitude, and ideal combination of scientific, operational, and academic knowledge. “The HiRO team understands in depth each local region’s-clinical trial landscape. Relationships and networks are important—it is essential to work with good people,” quotes Karen. In addition to that, HiRO provides biotech and pharma companies access to local experts in global regions. The global networks and partnerships have given HiRO a competitive advantage.

What does the future hold for HiRO?

HiRO is continuously identifying opportunities to grow in the global market and seeking M&A opportunities by expanding its geographical presence and widening its service portfolio. The company is constantly working further improve its services and aims to be a single solution for global clinical research problems. Description of the Company: Harvest Integrated Research Organization (HiRO) is a China-based globally oriented clinical research organisation (CRO). Company Name: Harvest Integrated Research Organization (HiRO)  Office Location: 33C2, Zhongyi Building, No. 580 Nanjing West Road, Shanghai Official Website of the Company: en.harvestiro.com Name of the Featured Leader: Karen Chu Designation of the Leader: CEO