Before recruiting patients on a clinical trial, the study goes through a study start-up phase which includes processes like ethics and regulatory approval & site identification/onboarding.
Ethics and regulatory processes are seen as a key limiting factor in the study start-up phase of a clinical trial.
Rapid start-up of clinical trials is invaluable to sponsors as the study can produce high quality data while being time- and cost-effective.
PhRMA recently put the average cost of a successful drug trial at around $2.6 billion. The cost per day can fall anywhere between $600,000 and $8 million. Global sponsors are looking at Australia and New Zealand to save time and money when running clinical trials.
Using ANZ as an advantage
Australia and New Zealand have some of the fastest and streamlined regulatory environments in the world. So, it’s no surprise that more and more biotechs are conducting clinical trials in this region. The ANZ region does not require an IND application to conduct clinical trials, unlike the US, saving up to a year in regulatory timelines and considerable costs for the sponsor. Furthermore, full GMP material is not mandated for Phase I clinical trials in Australia and New Zealand.
In addition to the streamlined ethics and regulatory processes, costs associated with these submissions are relatively low compared with many other regions, such as the US and Europe.
By leveraging the region’s streamlined processes, sponsors running clinical trials in ANZ will get the first patient enrolled faster than they would have anywhere else in the world.
Now how can biotechs use this knowledge about the ANZ region strategically in the clinical development of their products?
Global sponsors come to Australia and New Zealand to conduct early phase clinical trials. This allows the sponsors to generate high quality clinical data while being time- and cost-effective. The ANZ region’s rapid approval process provides the opportunity to support parallel applications to FDA with data collected from an earlier approved ANZ trial.
Through this strategic move, a biotech can streamline the clinical development of their product by leveraging the region’s ability for a rapid study start-up and conduct early phase clinical trials in ANZ while finalising regulatory applications with the FDA and EMA for later phase clinical trials.
Importance of a local CRO
When coming to the ANZ region, sponsors are turning to local CROs to help them navigate the ethics and regulatory frameworks. While regions like Australia and New Zealand present with some of the fastest Ethics and Regulatory approval environments globally, both come with unique regional and cultural requirements that play vital roles in the application process.
Local CROs, such as PharmaSols, have intricate knowledge of their country's ethics and regulatory requirements. They have strong relationships with both ethics and regulatory body representatives – assisting better communication. Local CROs can usually be notified about the availability for the ethics meetings, which can enable them to align the application hand-in accordingly to prevent a 2–4-week delay in the entire process.
In addition to this, we also have more established and trusted relationships with sites and local experts to gain insight regarding issues that may arise. These relationships within the industry assist with topics such as the specific standard of care available in the region for the indication of interest to align the study design accordingly, and the specific certification requirements (e.g., GMP certification) for the sponsors to run the clinical trial in the region.
The Value of PharmaSols in Rapid Study Start-up
The key to PharmaSols’ success is our dedicated in-house start-up team and regulatory expert. This team employs highly efficient processes to capitalise on Australia and New Zealand’s ethics and regulatory timeframes, providing sponsors with rapid and cost-effective solutions.
Now that we have discussed what the ANZ region has to offer along with why using a local CRO is the way to go, here are some recent examples demonstrating how PharmaSols can support your trials.
Understanding New Zealand’s centralised ethics and regulatory bodies' processes and timelines, PharmaSols swiftly obtained the necessary Ethics and Regulatory approvals prior to the first site initiation visit (SIV) – resulting in 35-day study start-up.
Similarly, for a complex Phase 1b oncology study, Rapid regulatory timelines were achieved in both Australia and New Zealand. In both countries, PharmaSols made regulatory submissions in 1 day. Full regulatory approval was granted in only 8 days in Australia and 13 days in New Zealand.
For a COVID-19 vaccine trial, PharmaSols submitted the necessary ethics application in one day and secured ethics approval in just 14 days. We obtained regulatory approval within just 3 days of receiving the final protocol.
Likewise, for a COVID-19 diagnostic trial, PharmaSols received ethics and regulatory approval in only 21 days from receiving the protocol.
PharmaSols is uniquely positioned in Australia and New Zealand, one of the world’s most trusted and rapidly growing clinical trial regions. With over 20 years of experience in this region and a team of dedicated experts, we support sponsors achieve rapid study start-ups for their clinical trials.
In addition to this, PharmaSols takes a creative problem-solving approach, has a trusted network of experts, and maintains a people-driven attitude, so you can be confident that your trial will remain on track and meet its targets.
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