While the rates of COVID-19 in the US, Europe and other parts of the world are higher than those leaders might like, New Zealand’s infection and death rates are very low. Citizens can attend concerts and rugby matches without a mask, and businesses can operate without the restrictions that make travel and trade challenging in other parts of the world.
For this reason, Kiwi contract research organizations (CROs) such as Pharmaceutical Solutions (PSL) are enjoying increasing interest in their operations. Outsourcing-Pharma (OSP) recently spoke with managing director Jacquie Palmer (JP) about the phenomenon, and what it means for the future of clinical research in the region.
OSP: Could you tell us about the evolution of the clinical trials industry in New Zealand – how has it grown and changed over the years? person
JP: In terms of size, the clinical trials industry in New Zealand has been relatively stable over the last five years; recently, we have seen increased interest in NZ for early phase studies, particularly in the therapeutic fields of oncology, neurological diseases and infections. New Zealand has one of the highest rates of asthma and respiratory disease in the world and we would like to see more global trials coming into the region for this therapeutic field, where we have strong patients and top opinion leaders.
New Zealand has a strong history of conducting successful ‘rescue studies’, where recruitment has become difficult internationally and new geographic areas have to be considered. This is common in flu-like seasonal studies, where the Southern Hemisphere effectively extends the Northern Hemisphere winter and therefore the patient recruitment period is extended.
OSP: Please share how the COVID-19 pandemic initially impacted New Zealand and the pilot landscape in the country, especially in the months since it hit until now. person
JP: Clinical trials in New Zealand are seen as an essential service by the government, which means that the site and CRO can work closely together since the Covid-19 lockdown began. Sites in New Zealand are moving quickly to introduce new secure document exchanges to facilitate remote monitoring, and we are trying to understand the status and different approaches of each site to remote monitoring.
To ensure continuity of trials, Pharmaceutical Solutions has adopted an agile response. Is the site capable of remote monitoring and is it possible for patient visits or on-site monitoring visits? As we raise and lower the alert level, does this approach change?
The strength of our relationship with the site means that the Pharmaceutical Solutions is always up to date with the monitoring status of each site and we easily switch to remote monitoring.
Just two days after the first lockdown began in New Zealand, our team carried out remote monitoring at a location that only two days earlier, was remotely incapacitated. We take great pride in the speed and attitude of being able to demonstrate by our site and our CRAs that made this happen.
During the initial outbreak of COVID-19, Pharmaceutical Solutions looked at several existing and new company studies underway both globally and in New Zealand. Now, we are seeing increasing interest in New Zealand. With a relatively low community transmission rate, NZ is now seen as a safe choice for clinical trials where trial continuity is guaranteed.
In other countries, COVID-19 prevents patients from taking part in clinical trials and disrupts health systems treating those with the virus. As a result of these factors, companies are looking to other geographic areas to provide clinical trials.
OSP: What about NZ which makes it an attractive location for clinical trials? person
JP: Australia and New Zealand are home to some of the world’s best researchers, health professionals and high-quality clinical research sites. With a stable socio-political environment and an international reputation for quality and integrity, the region can be trusted to provide accelerated, cost-effective and quality clinical trials of quality; New Zealand in particular provides global sponsorship with one of the fastest regulatory approval environments in the world.
Our network of partners has proven that an accelerated ethics and regulatory framework can get started in 35 days, and we consistently deliver fast hiring and quality results that are superior to many global CROs.
OSP: Please tell us about the situation in the Auckland Clinical Study – I understand this site in full capacity. person
JP: Clinical Studies Auckland is a Phase I clinical trial site, and in response to increased interest in New Zealand, they are currently in full capacity. However, Pharmaceutical Solutions is working with a number of other Phase I units in New Zealand, and there is industry capacity at all phases as the clinical trials industry recovers from COVID-19 and positions itself for growth.
OSP: Can you tell us about Pharmaceutical Solutions – who you are, how you grew, and what sets you apart (apart from being the only CRO NZ has)? person
JP: Pharmaceutical Solutions is considered to be one of the leading private CROs in the Australia and New Zealand region. We provide full-service clinical research and regulatory / ethics management to global and local clients, from study inception, to trial completion, for all phases of clinical trials.
In the past year, our work has multiplied repeat business from clients. We’re proud to say that after the organization tried New Zealand and PSL, they came back and worked with us again.
Pharmaceutical Solutions strives to continuously deliver clinical trials to the highest standards. A can-do attitude and strong relationships drive our business to consistently deliver what sometimes seems impossible. We all work hard and carry on with it, even when the going gets tough.
OSP: How are you working to attract new trials and transition to NZ? How can you help new and ongoing trials make that transition, and make it as smooth as possible? person
JP: Despite travel restrictions, we are unable to attend traditional trade shows to promote New Zealand globally; and PSL, like many other businesses, has enhanced our digital marketing presence. We strive to convey the message that NZ and PSL can assist overseas companies wishing to undertake clinical studies in areas where continuity is guaranteed.
As we look ahead and collectively continue to navigate COVID-19, we recognize that globally we are all in the midst of very uncertain times. The world today needs quality research more than ever and it is a privilege to be part of an industry that is more important today than ever.
PSL’s depth of experience in the region and NZ’s relatively strong COVID-19-free position has uniquely positioned us to support the global clinical trials industry.
OSP: Do you have any sample trials you’d like to share that have been successfully launched or transitioned to NZ? person
JP: In the last three weeks, Pharmaceutical Solutions has seen three new studies starting from three new clients who are new to the region. All three were unable to start studies in other regions because of the impact of COVID-19.
Clinical trials are complex, and they really need a team of local experts to ensure a successful trial. We look forward to establishing strong and ongoing relationships with these new clients as we support their studies and help them benefit from the world-class clinical research capabilities and healthcare infrastructure in the region.
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