Southern Star Research, an Australian and Asia-Pacific CRO specializing in clinical trial acceleration with FDA data compliance, has been accredited by the Australian Government Office of the Gene Technology Regulator for gene and cell therapy clinical trials.

This is the accreditation CROs in Australia require for gene and cell clinical trials.

Southern Star Research, Director Corporate Development, Chris Stellatos said this accreditation is a significant development for the company as biotech demand increases for cell and gene therapy trials. It follows a robust assessment process that has taken more than 3 months.

He said Australia has positioned itself as the most attractive clinical trial destination for these trials.

“Supportive rebates, scientific excellence, and rapid approval processes including no requirement for an IND make Australia the stand-out location to conduct clinical trials.”

“The Australian Government has made all the right financial and regulatory adjustments to support the sector and the winners are biotechs.”

“The attractive benefits apply to Australian and overseas biotechs and are designed to launch biotech clinical programs quickly and cost-effectively.”

Benefits of conducting trials in Australia include:

• A streamlined approvals process, resulting in as short as a 4-8 week timeline from submission to site initiation
• A favourable regulatory framework – no need to lodge an Investigational New Drug (IND) application
• Generous cost savings and tax incentives – potentially up to 60% less than the US, EU and other major jurisdictions
• World-class facilities, medical infrastructure and talent, resulting in data accepted by the FDA, EMA and other regulators

The streamlined clinical trial approvals process in Australia means a study can be approved in less than 8 weeks and avoid an IND.

The process timeline includes:

• The Human Research Ethics Committee (HREC) approval process takes 4–6 weeks on average. Site governance documents are submitted concurrently and typically take 6-8 weeks.
• Clinical Trial Notification (CTN) is the final step in the approvals process.
• Confirmation from the TGA is usually received within 2–3 days, allowing the sponsor to formally commence the study.

About Southern Star Research www.southernstarresearch.com

Founded in 2010 and headquartered in Sydney, Australia, Southern Star Research is a full-service CRO helping sponsors to navigate the complexities of bringing new medical products to market. Since commencing operations in Sydney, we have grown to become an international team of specialists, managing studies across the globe.

With a focus on the biotechnology and medical device industries, we offer flexible and bespoke solutions that meet the unique needs of each project. While we have experience across all study phases, we are early phase specialists (Phase 1 and 2) with particular expertise in designing and managing clinical trials that ensure your asset is ready for larger Phase 3 and 4 studies, licensing, partnering and acquisition.

We believe a customer-first approach, transparent relationships and a proactive team of experts are the best path to achieving successful commercial outcomes for our clients.