Southern Star Research Achieves ISO 9001 Certification for the Second Consecutive Year with Zero Findings
Sydney, Australia – 29 August 2025 – Southern Star Research (SSR), a leading Contract Research Organisation (CRO), is proud to announce that it has successfully achieved ISO 9001 certification for the second year in a row, once again with zero findings. This achievement highlights SSR’s continued commitment to quality management and operational excellence.
ISO 9001 is the internationally recognised standard for Quality Management Systems (QMS), based on principles such as customer focus, leadership, engagement of people, and continual improvement. Certification confirms SSR’s ability to consistently deliver services that meet both regulatory requirements and client expectations.
The ISO audit team commended SSR’s quality systems and collaborative culture, noting the company’s strong focus on maintaining high standards and continuous improvement.
Kellie Lantry, Head of Quality Assurance at Southern Star Research, said: “The audit was constructive and smooth, making the process simple and enjoyable for the organisation. We greatly appreciated the audit approach and look forward to continued collaboration as we build on this strong foundation.”
Since the previous ISO 9001 certification in 2024, SSR has made significant progress, including:
- Expanding its global workforce
- Strengthening its business development presence in Asia and the US.
- Introducing new service offerings in biometrics, safety and data management.
These developments demonstrate SSR’s ability to grow while maintaining strong quality processes across its operations.
SSR continues to operate within a highly regulated environment, guided by ICH GCP, ISO 14155, PIC/S GMP, FDA 21 CFR Part 11, the Australian Privacy Principles, GDPR, and NHMRC ethical frameworks, upholding the highest standards across all areas of its business.
About Southern Star Research
Southern Star Research is a full-service CRO dedicated to navigating the complexities of bringing new medical products to market. With a legacy of excellence that began 14 years ago in Sydney, we have grown from a small, passionate team into a global network of experts committed to delivering high-quality services in medical writing, clinical monitoring, project management, biostatistics, data management, safety and medical monitoring, and quality assurance.
Southern Star Research has been recognized for its outstanding contributions to the field, winning prestigious awards such as the Great Place to Work in Australia in 2024 and 2025, APAC CRO of the Year 2025, and the Frost and Sullivan 2024 Asia-Pacific Competitive Strategy Leadership Award. Our international team continues to deliver innovative clinical trial solutions across diverse therapeutic areas, ensuring the success of every study we manage.