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Australia’s Most Trusted Contract Research Organization

Southern Star Research is one of the most trusted CROs in the Asia-Pacific region, with a wealth of experience in biotech, pharmaceutical and medical device trials.

As a full-service CRO, our team comprises experts in medical writing, clinical monitoring, project management, biostatistics, data management, safety and medical monitoring, and quality assurance.

Whether you’re just starting your clinical journey, ready for Phase 2 or 3, or trying to rescue a failing study, we’re here to talk through your options. Fill in the form to get in touch!

Get in touch!

Benefits of working with us

Agility

Our agile, proactive, and bespoke solutions help you reach your commercial goals faster.          

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.          

Transparency

We pride ourselves on our transparent, close relationships with an in-depth focus on your unique needs.

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.

Rescue studies

Has your trial been derailed or failed to meet your service requirements?

There are many reasons why clinical trials may need ‘rescuing’. Resource shortages, recruitment shortfalls, poor management, or contractual failures can quickly lead to blown-out project timelines, substantial delays and additional costs. However, with the right interventions, your study doesn’t have to fall behind.

At Southern Star Research, we have experience rescuing studies previously managed by all our main competitors, including Novotech, Avance, and George Clinical. We’re also proud to say that none of our trials have ever needed rescuing by other CROs.

Book a meeting with us to discuss your study and what strategies we can deploy to get it back on track.
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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.
  • 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
  • We help turn complexity into clarity throughout the drug development process through flexible and quality-driven clinical study solutions to meet your unique needs
  • We’re a cross-functional team of experts that work side-by-side with you toward a common goal
  • We’re upfront and transparent in our pricing - no unexpected add-ons down the line
  • We ensure that everything we do is built upon a strong backbone of dependable data, results and insights
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What our clients say

“As you know we have wrapped up the project, and I wanted to let you know that our internal PM, had really great things to say about your team at the wrap up of the study, especially your PM. Thank you for your commitment to the project and your help with the client over the years.”

Vice President

US based CRO (Pancreatic Cancer)

“I just wanted to touch base to sing praises about your wonderful CRA, now we have handed over responsibilities for the trial. They are such a pleasure to work with! We are really going to miss having them on our team. He has the most lovely manner of working and is flexible, positive, organised and we have loved having him on board with us”

Global Clinical Trials Manager

Australian Pharmaceuticals (Urology)

“Thank you all for doing a lot of preparatory works during SSU period, let us keep up our good work and effective communication so as to let a high-quality study delivered. Thanks again!”

Clinical Operations Manager

Chinese Biotech (Healthy Volunteer)

“I just wanted to say Thank you for a fantastic job you do with our SAEs and staying on top of everything. It is a real pleasure to work with you and I appreciate all you do to support our study.You do a fantastic job!!”

Head, Clinical Operations

US Biotech (Epilepsy)

“I would also like to thank you and your colleagues very much for your dedicated and thorough work on this issue and that I am appreciating very much to work with all of you on the other side of the earth i.e.: Down Under!;-) !”

Vice President, Head of Clinical Pharmacology

Swiss Pharmaceutical company (Diabetes)

“On behalf of the Clinical Team I would like to thank-you for your wonderful assistance with our ethics application and also soon to be submitted, our SSA forms. Your assistance has really helped our team and enabled us to keep on track to submit according to our internal deadlines. Thank-you for all your advice, reviews and creation of documents.We look forward to working with you again.”

Clinical Development Medical Physicist

Australian Biotech (Oncology)

“Your CRAS are top notch and I would work with Southern Star Research any opportunity I could get! Thank you. I know this program was a head banging experience for the team, and they handled it all beautifully.”

Project Director, Clinical Operations

US CRO (Oncology)

FAQs

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.

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.

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.

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.
Head Office:
Phone: +61 2 9011 6266

L1, 1 Merriwa Street,

Gordon, NSW, 2072 Australia

E: info@southernstarresearch.com 

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Specialist experience

Each member of our Leadership Team boasts an average of 30 years experience. Our clients have access to an extraordinary group of Clinical Research professionals, whose experience covers Multinational Pharmaceutical companies, Biotechnology, Medical Device, CRO’s, research institutes, Universities, Industry Associations & Government Bodies. Together, we ensure that every aspect of your unique and novel drug study  clinical trial is handled with scientific precision, care, and foresight.

Our team has all of the tools, knowledge and experience to solve almost any issue that may arise during the complex clinical trial process.

We recognize that each study is unique and different and there are nuances that need to be resolved proactively.

Our advisory board of top-tier specialists in multiple therapeutic areas engage in the early stages from protocol design in constructive discussions to anticipate challenges and enhance study efficiency throughout the study.