Rare Disease CROs in Australia

Melbourne-founded CRO supporting small and mid-sized biotech companies across all clinical development stages including regulatory affairs, biometrics, and manufacturing scale-up.

Australian full-service CRO providing Phase 1–3 clinical trial management with expertise in biotech-focused programs. Known for the Australian Clinical Trial Notification (CTN) regulatory pathway advantage.

Australian full-service CRO focused on early-phase clinical trials in oncology, rare disease, and dermatology, leveraging Australia's Clinical Trial Notification scheme for faster trial start-up.

Australian CDMO providing API manufacturing, sterile fill-finish, and pharmaceutical development services from TGA-licensed and FDA-registered facilities in Melbourne.

Perth-based clinical trial site and CRO specializing in Phase 1–3 studies across multiple therapeutic areas. Located at the Harry Perkins Institute of Medical Research.

Australian not-for-profit pharmaceutical company developing and registering medicines for neglected tropical diseases, providing regulatory and clinical development services for global health products.

Asia-Pacific specialist CRO providing full-service clinical development capabilities with deep expertise in the Asia-Pacific regulatory landscape.

Leading Australian Phase 1 clinical trials unit operating in Melbourne, Brisbane, and Minneapolis. Specializes in first-in-human, oncology Phase 1, and healthy volunteer studies with rapid enrollment timelines.

Independent Australian full-service CRO specializing in pharmaceutical, medical device and biotechnology clinical trials, award-winning APAC CRO of the Year.

Physician-led Australian CRO offering full-spectrum clinical and non-clinical services with AI-driven operating model across Phase I-III for innovative biotechs.