There are many factors that can lead to the derailment of a clinical trial. Your Clinical Research Organisation (CRO) partner shouldn’t be one of them.
Understanding the importance of different regional benefits, individual organisations' responses to the pandemic, and their size can help this critical decision.
When faced with many CRO options, the first step to narrowing them all down is choosing your trial’s location.
Australia and New Zealand is a growing preferred destination for global clinical trials. New Zealand’s and Australia’s robust research infrastructure and stable socio-economic climate, along with its streamlined ethics and regulatory application processes, allow for rapid start-ups while also avoiding costly delays. The Australian government strongly supports research studies, offering substantial rebates and a similar accelerated timeline for ethics and regulatory applications.
Both regions are accepted by the FDA and EMA and do not require a US pre-IND.
As important as it is for these streamlined processes to be implemented in clinical trials, it must still be done in a way that does not sacrifice the quality of the data. Australia and New Zealand are hosts to world-class research hubs and facilities, have access to key opinion leaders and highly skilled and qualified research professionals, all of which contribute to quality data outcomes.
While the benefits of running a trial in Australia or New Zealand are clear, it’s equally important to align with a CRO that has a thorough understanding of the region, its participant population, and different processes.
As the pandemic continues and new variants arise, there is increased importance in selecting the right CRO.
Location again plays a key role in this selection process. Australia and New Zealand have historically had low levels of COVID-19 transmission, making it easier for patients to travel and participate in trials and for the trials themselves to run uninterrupted. Both countries have classed clinical research as an essential service, allowing them to operate throughout a lockdown. Additionally, sites can facilitate remote monitoring and telehealth capabilities due to the world-class research infrastructure in place and the uptake of technology. This allows for critical patient recruitment and site monitoring, making it important to engage with a CRO that has proven experience in remote monitoring capabilities to ensure continuity and compliance.
Expedited ethics and the regulatory processes are in place to obtain fast approval for COVID-19 related clinical trials.
Often large global CROs seem like a safe CRO choice simply because of their size and full service offering. While smaller CROs may not have all in-house clinical trial services, outsourcing some of the highly specialised areas to an established and trusted network of experts strengthens overall service quality. Larger organisations can also have many negative implications on the overall success of a trial.
Currently, we are seeing larger global CROs involved in complicated global acquisitions creating noise and disruption within the organisation. Clinical trials and the focus on day-to-day clinical trial management risks are often overlooked during these transitions.
Often larger organisations are tied to concrete processes and are seldom able to stray from them. This leaves little room for innovative problem solving and only allows for cookie-cutter solutions. Small boutique CROs aren’t constrained by cookie-cutter solutions, which afford more opportunities for a more flexible problem-solving approach, which best fits your clinical trial needs.
Along with internal disruptions and a lack of creative solutions, engaging with a bigger CRO can also mean sacrificing customer service. Through a smaller, more boutique CRO, you experience a high level of interaction and focus due to each unique clinical trial's relative scale and importance.
PharmaSols is a CRO that can help you meet your clinical trial objectives through our unique regional benefits, proven remote capabilities, and ideal size. With our creative problem-solving, trusted network of experts and people-driven attitude, you can feel confident that your trial will remain on track and meet its targets.