20 Dec

HiRO – our global advantage, tailored solutions and key partnerships

Last year we announced that PharmaSols was acquired by global CRO, Harvest Integrated Research Organisation (HiRO) – recently announced as the Top CRO in the APAC region. Through HiRO, we were able to offer a larger global network, stronger leadership and investment in market-leading integrated systems and processes. This month we will discuss a bit more about our parent company HiRO – their values, vision, service offerings, partnerships, and end-to-end specialised clinical trial solutions.

HiRO is an emerging full-service global CRO offering biotechs rapid, cost-effective, and reliable clinical trial solutions to fit their specific needs.  

The HiRO Global Advantage

Through PharmaSols (HiRO subsidiary), HiRO provides global biotech access to Australia and New Zealand, one of the most mature markets in the Asia-Pacific region for conducting clinical trials. The ANZ region is consistently ranked as one of the best places in the world to conduct global clinical studies. Home to some of the world’s best researchers, health professionals and high-quality research sites and with an international reputation for quality and integrity, each year around 2000 research projects are carried out by global pharmaceutical, medical device and biotechnology companies, spending more than USD$1.4 billion annually on clinical trials in this region.

With over 20+ years of operating in this region, PharmaSols has both an international global presence and an extensive local network with Sites, Labs, Lead investigators, Key Opinion Leaders, research institutions and research support networks.

US companies are driven by fast approval times and lower costs and comparable quality. As Australia and New Zealand do not require a US IND, often early phase trials are started in this region first. Asian companies seek quicker, transparent approval processes with results that are acceptable to the US FDA, Europe’s EMA and China’s CFDA. Generally, clinical trials in this region can save Asian sponsors between 6-9 months of start-up time. This can contribute to considerable unquantified cost savings in terms of faster commercialisation pathways.

This region’s clinical research data is accepted by all major regulatory authorities around the world. The ANZ region is considered by many as the “Go to Region” for foreign biotech companies that see the benefits of conducting early-stage clinical trials in the region, shortening study start-up timelines, and resulting in significant savings in the commercialization pathway.

Initially, biotechs new to the region are attracted here to conduct early-phase clinical trials but sponsors are now staying beyond their Phase I studies. The ANZ region has recently seen exceptional growth in Phase 2 studies and more recently Phase 3 activity in this region is increasing, as global sponsors discover Australia and New Zealand are exceptional cost-effective medical research locations, especially amid a global pandemic.

Increasingly clients are seeing the advantages of expanding from an Australian multi-site Phase1/2 study, into a Phase 3 study, adding on additional global regions, such as China and Europe to increase patient numbers and diversity.

Rolling the next Phase of a study using the same sites and CRO can save valuable time and result in trial cost savings. The Australian R&D 43.5% tax cash-back rebate is applicable to Phase 1- 3 studies, so it can make sense to maximise the time and cost advantages of the region to deliver high-quality, regulatory-ready data.

Australia and New Zealand outperform many other regions in terms of quality and compliance. Through strong site networks and innovative recruitment methods, this region continuously demonstrates it can deliver strongly on both patient/participant recruitment targets and on the speed of recruitment.

“The AU NZ region is seeing extraordinary growth in early phase clinical trials as global sponsors are seeing the region's benefits in rapid start-up. HiRO offers global sponsors access to geographic regions where larger patient populations are required for some later phase trials, especially high-population areas in Asia, using the same global team of experts. Every clinical trial is different, we recognise this and provide a range of flexible solutions.” – Jacquie Palmer Managing Director PharmaSols

HiRO’s global model is quite simple. They support biotechs down in the ANZ region for early-phase trials where they can leverage the regional benefits of rapid study start-up and cost-effective and proven patient recruitment.

The global HiRO group is well-established in Australia, New Zealand, China, and Taiwan and is in the process of expanding to several other countries, including the US.

HiRO’s ever-expanding global reach provides global support for the expansion into later-phase clinical trials or clinical trials where large populations are needed to ensure patient recruitment.

HiRO offers something for everyone

HiRO categorises biotechs into 3 different groups and addresses their distinct needs in a highly intuitive manner. We recognise each biotech is in a different stage of its business cycle and we focus on supporting them in the best way possible.

1. Start-ups + small firms – CMC, protocol review, clinical trial (regulatory) strategy development. HiRO provides fast and cost-effective solutions to increase the current and future value of their compound.
2. SME’s ready to enter Phase 1 and 2 studies – experienced project management and clinical management. Industry and regulatory know-how. Team of experts present in many regions. Saving time and money by being proactive in planning for the next phase of trials.
3. Biotechs conducting later phase global trials – access to “one global team” across Asia, the Pacific, the US and the EU. Reliable partner for biotechs and pharma firms seeking to establish a footprint in these regions and maximise their access to patients.

Key Partnerships – expanding our service offering 

Through our laboratory to patient model, HiRO partners with other key providers to add further expertise and breadth to its service model. 

HiRO has partnered with a CDMO to provide our clients with manufacturing capabilities, resulting in faster commercialisation for their products.

Biopharmaceutical manufacturer Peking University Biologics (PKU BIO) provides one-stop biopharmaceutical Contract Development and Manufacturing services for start-up projects. With the goal of bringing new medicines to patients faster and with more successful outcomes, the two organisations recognise the need to work more collaboratively to get new medicines into the international biomedical market more quickly, helping global biotechs advance rapidly and cost-effectively from pre-clinical lab work to clinical trials, and onto full-scale commercial production.

HiRO has partnered with Cluepoints to increase clinical trial efficiency and reduce deviation and bias to obtain accurate patient outcomes. Cluepoints a premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software, provides Risk-Based Quality Management (RBQM) expertise and technology allowing sponsors and CROs to quickly implement specific risk management solutions, offering the industry assurance that key risks are identified, mitigated, centrally addressed, and monitored with confidence.

“We are delighted to be working with HiRO to help increase the adoption of RBQM approaches in the Chinese market and offer this best-in-class solution for CROs. Our RBQM expertise, combined with HiRO’s experience and knowledge of the particular challenges in the region, will increase clinical trial efficiency and patient outcome accuracy resulting in improved patient safety and faster market approval.” - Patrick Hughes Co-Founder and Chief Commercial Officer Cluepoints

“Combining the professional RBQM system at CluePoints and HiRO's own extensive clinical trial service experience means we can expand specific markets. This partnership will not only bring the concept of highly specialized RBQM data analysis to the Asia-Pacific market, but it will also act as a catalyst for the region’s industry as a whole to upgrade and respond to the digital clinical trial movement.” - Allen Lin, Head of Quality Management at HiRO.