• Southern Star Research announces APAC expansion plans 2023
• South Korea office is stage 1 of APAC roll-out
• Singapore next office in expansion program – scheduled for mid-2023
• Designed for biotech clients to access the benefits of APAC for rapid and high-quality trials

Southern Star Research, an Australian CRO specializing in clinical trial acceleration with FDA data compliance, announced at Biotech Showcase its expansion into South Korea to offer clients access to medical and clinical excellence and patients in the region.

The Seoul, South Korea office is expected to open next month and the Singapore office to follow. The Singapore office will serve as the hub to support the Asia region.

The Southern Star Research team is available for meetings at Biotech Showcase to discuss the benefits of conducting trials in Australia and APAC. Book a meeting with Southern Star Research via Partnering One
Southern Star Research, CEO David Lloyd said while Australia has regulatory and tax benefits making it an attractive clinical trial destination, South Korea offers an excellent environment for later-phase trials.

“South Korea’s large and diverse therapeutic area patient populations, supportive government regulatory environment, and medical excellence is attracting clinical-stage biotechs from around the world.”

He said the combination of Australia, with supportive rebates, scientific excellence, and rapid approval processes including no requirement for an IND, and then access to South Korea and Singapore is a compelling offering.

“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 CRO has recently become accredited to deliver gene and cell therapy clinical trials for biotech sponsors.

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

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.