08 Mar

PharmaSols’ Global Solution

PharmaSols is the oldest and best-connected privately-owned Clinical Research Organisation in the Pacific region. Having successfully supported patient needs and delivered outstanding clinical trial results for more than 20 years, our addition to the global group HiRO in November 2021 means we now provide flexible end-to-end integrated solutions to sponsors around the globe. 

PharmaSols offer a global solution which includes:

• A full-service offering provided by a global team with expertise in data management, statistics, medical monitoring, medical writing, safety and pharmacovigilance. 
• Clinical Trial design flexibility to allow sponsors the freedom to tailor a unique clinical trial structure that best suits their specific requirements using 
• a PharmaSols full service team or 
• leveraging our global external network for specialised service offerings or 
• integrating with sponsors own internal team.

A flexible global solution providing high-quality results – a one-stop-shop for all critical processes involved with clinical trials.

Biotechs often struggle to develop internally drug development pathways that streamline the entrance of new drugs and devices to market. As part of the global HiRO group, PharmaSols has access to a network of organisations that are critical in the drug development pathway, providing integrated end to end clinical trial solutions.

HiRO recently entered into two new strategic agreements that add further expertise and resource to this network. 

Biopharmaceutical manufacturer Peking University Biologics (PKU BIO)

• In January 2022 HiRO and PKU BIO announced a Strategic Cooperation Agreement for expanding the research and development capabilities of both organisations. 
• The partnership provides one-stop biopharmaceutical Contract Development and Manufacturing services for start-up projects, from “Gene/cell to GMP”.  This includes gene design/optimization, process development, CMC preparation, IND application (NMPA, FDA, EMA, PMDA, etc.), IP manufacturing, BLA, and commercial manufacturing in compliance with the respective regulatory requirements and GMP standards, 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.

Risk-Based Quality Management system CluePoints

• In December 2021, HiRO began a collaboration with CluePoints, which provides cloud based analytical solutions to oversee and manage risk across the entire clinical trial lifecycle. Its approach is based on guidance from the ICH (International Council for Harmonisation) E6(R2) Good Clinical Practice, the FDA (US Food and Drug Administration), the EMA (European Medicines Agency) and the UK MHRA (Medicines and Healthcare products Regulatory Agency).
• CluePoints’ products support traditional on-site monitoring and enables centralised oversight allowing study teams to quickly implement specific risk management solutions and ensure key risks are identified, mitigated, centrally addressed, and monitored with confidence. 
• The partnership with CluePoints, combined with the global HiRO group’s experience and knowledge of the industry, will increase the safety, efficiency and accuracy of clinical trials by improving data quality, resulting in reduced timelines, costs and faster market approvals. 

As an established CRO in Australia and New Zealand, PharmaSols is recognised for its capabilities and expertise in conducting both early and later phase trials in the AU NZ region. We are known for rapid study start-up timelines as short as 35 days, cost-effective patient recruitment outcomes, and FDA/EMA-recognised quality data. 

As part of the global HiRO group, PharmaSols can leverage an ever-expanding global reach to provide global support for later phase clinical trials and further reduce development timelines for sponsors. The global HiRO group is well established in China and Taiwan and is in the process of expanding to several other countries.

Early phase trials being pulled into AU NZ

“The AU NZ region is seeing extraordinary growth in early phase clinical trials as global sponsors are seeing the regions benefits in rapid start-up. Now with our relationships with HiRO we can offer global sponsors other geographic regions where larger patient populations are required for some later phase trials. Every clinical trial is different, we recognise this and provide a range of flexible solutions.” 

Jacquie Palmer PharmaSols Managing Director

With over 20 years of experience in Australia and New Zealand, we have established a trusted network of experts in this region and can now offer even more flexibility in providing solutions for sponsors. Get in touch with us to see how we can help support your trial, from beginning to end.