Your full-service contract research organization
As one of the most experienced contract research organizations in the Asia-Pacific region, we know that no two clinical trials are the same.
That's why we blend our extensive experience in therapeutic areas with a customer-centric approach to deliver high-quality and cost-effective trials aligned with global standards. Through a completely personalized partnership, accessible expertise, unshakeable attention to detail, and scientific rigour, we guide you through the complexities of bringing new medical products to market.
Benefits of working with us
Agility
Our agile, proactive, and bespoke solutions help you reach your commercial goals faster.
Quality
We’re a contract research organization (CRO) with a track record of delivering the best quality and utmost safety at a predictable price.
Transparency
We pride ourselves on our transparent, close relationships with an in-depth focus on your unique needs.
Simplicity
We simplify the clinical trial process to help you navigate each stage with confidence and clarity.
The Australian Advantage
Cost
Eligible organisations receive a 43.5% cash rebate on trial costs with the Australian Research & Development tax incentive.
Speed
Get you trial up and running in 8 weeks with streamlined ethics approvals and no need for an Investigational New Drug application.
Quality
World-class healthcare facilities and renowned experts ensure your data is accepted by international regulatory bodies like the FDA and EMA.
Our Services
Our experts will work directly with you as an extension of your team. We listen to you, employ a customer-first approach to your project, and share in a commitment to your success. We specialize in the following:
Phase 1-3 Trials
Our experienced team will help you obtain high-quality data throughout the trial that will appeal to future investors and prepare your product for larger pivotal and post-marketing studies, partnerships, licensing, and sale.
Clinical Operations
With established relationships with investigators and site staff, we help you perform all aspects of clinical trial operations to the highest standard. From startup to monitoring to ongoing project management.
Biometrics
Our data managers, biostatisticians and programmers have the experience and discipline to ensure we can offer you the highest quality biometric services, leading to deeper, more rigorous insights.
Safety & medical trial monitoring
With the support and guidance of our medical officers, any adverse events in your clinical trial will be identified quickly and managed professionally. This gives you confidence that your final safety review will represent your product’s viability.
Medical writing
Our protocol and CIP writing are bolstered by our in-depth knowledge of treatment practices and scientific evaluation capabilities. Plus, we can present your study results, analysis, and interpretation accurately, clearly, concisely, and in compliance with international regulators’ requirements.
Partnerships
Are you a like-minded organization looking to deliver clinical trial services that compliment your offerings? Are you looking to extend your capabilities into Australia and the Asia Pacific? We’ve got you covered. Partner with us so we can help you deliver on your projects.
Why choose SSR?
When you work with Southern Star Research, you work with one of the top contract research organizations in the Asia-Pacific region.
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We’re your full-service contract research organization with the capability to guide you from first-in-human phase 1 trials through to phase 3 patient trials
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We help turn complexity into clarity throughout the drug development process through flexible and quality-driven clinical study solutions to meet your unique needs
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We’re a cross-functional team of experts that work side-by-side with you toward a common goal
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We’re upfront and transparent in our pricing - no unexpected add-ons down the line
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We ensure that everything we do is built upon a strong backbone of dependable data, results and insights
What our clients say
“Their expertise is second to none, they are on the ground working with sites intimately with close attention to detail to ensure that the job gets done. With Southern Star Research you don’t feel like you’re dealing with a big organization - you get a face-to-face personal approach.”
Director of Regulatory Affairs
“SSR take time to find out how we work and are solutions-focused, suggesting things that might help our business. They invest in great outcomes and are willing to think about the long-term relationship and how they might work with their partners.”
Head of Trial Management & Monitoring
“Working with Southern Star Research gives us a level of security. You know your trial will be delivered as expected without surprises. Communication is easy and they are flexible. We talk through issues and adapt continuously to fine-tune and tailor to what we need.”
Clinical Trials Program Manager
“Their expertise is second to none, they are on the ground working with sites intimately with close attention to detail to ensure that the job gets done. With Southern Star Research you don’t feel like you’re dealing with a big organization - you get a face-to-face personal approach.”
Director of Regulatory Affairs
“SSR take time to find out how we work and are solutions-focused, suggesting things that might help our business. They invest in great outcomes and are willing to think about the long-term relationship and how they might work with their partners.”
Head of Trial Management & Monitoring
“Working with Southern Star Research gives us a level of security. You know your trial will be delivered as expected without surprises. Communication is easy and they are flexible. We talk through issues and adapt continuously to fine-tune and tailor to what we need.”
Clinical Trials Program Manager
FAQs
How long does the clinical trial approval process take in Australia?
Your study can be approved in less than 8 weeks. The ethical review process takes 4–6 weeks on average and site governance documents are submitted concurrently, which typically take 4-8 weeks. The Clinical Trial Notification (CTN) is an important step in the approvals process and is usually received within 3-5 days.
Can an Australian contract research organization fast-track the process?
You can’t cut corners in the Australian regulatory process. However, partnering with a contract research organization like Southern Star Research, which is well-versed in conducting studies compliant with Australian regulations, can remove complexity and streamline the process for you.
How much do clinical trials cost in Australia?
This is case-by-case dependent. However, patient, site, and labor costs are significantly lower than in the US, EU, and some parts of Asia, which reduces your funding requirements. Additionally, our templated clinical trial budgeting processes reduce uncertainty around trial expenses and give you clarity over project costs.
What is the R&D tax incentive in Australia?
The Australian Government offers one of the most generous Research & Development (R&D) tax incentives in the world, with up to a 43.5c cash rebate for every $1 spent for eligible research activities.