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 bioanalytical CRO providing GLP-compliant LC-MS/MS and ligand binding assay services for pharmacokinetic, bioequivalence, and immunogenicity studies supporting global regulatory submissions.

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.

Adelaide-based Phase 1 clinical pharmacology unit conducting first-in-human, bioequivalence, and biosimilar studies. Operates a 150-bed facility at the Royal Adelaide Hospital campus.

Full-service Australian CRO delivering clinical research services across Australia and New Zealand, supporting sponsors through Phase I-IV development.

ISO 9001-certified full-service CRO with offices in Australia, Singapore, and India providing Phase I-IV trial management across the Asia-Pacific region.

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.

Novotech's dedicated Phase I research unit in Sydney providing first-in-human, SAD/MAD, food effect, and bioavailability studies with a 30-bed clinical pharmacology facility.

Adelaide-based Australian Phase I clinical pharmacology unit within the Royal Adelaide Hospital, conducting first-in-human, BA/BE, and cardiac safety studies with a 48-bed facility.

Australia's original full-service CRO since 1987, managing clinical research across all phases and most therapeutic areas for pharma, biotech and medical device companies.

Melbourne-based CRO specializing in Phase I-IIa first-in-human studies, offering rapid trial startup under Australia's CTN scheme with access to leading Australian clinical pharmacology units.

Asia-Pacific focused full-service CRO providing clinical trial management, data management, and biostatistics services with particular expertise in cardiovascular, renal, and diabetes trials.

Academic CRO based at Griffith University on the Gold Coast, conducting clinical trials in metabolic disease, sports medicine, and natural health products under TGA regulatory framework.

ICON's Australian operations leveraging Australia's CTN scheme for rapid Phase I trial initiation, supporting multinational sponsors with early-phase development in the APAC region.

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.

Australian boutique CRO specialising in early-phase and first-in-human MedTech clinical trials across Australia, New Zealand, and the USA.

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.

Australian pharmaceutical research company providing preclinical and clinical development services with expertise in inflammatory bowel disease and gastrointestinal therapeutic areas.

Australian CRO helping global pharma and biotech leverage the regulatory and cost advantages of clinical trials in Australia and New Zealand.

Brisbane-based Phase 1 clinical trial unit specializing in first-in-human, pharmacokinetic, and vaccine studies. Operates a dedicated clinical pharmacology unit at QIMR Berghofer campus.

Sydney-based Phase 1 clinical pharmacology unit specializing in first-in-human studies, bioequivalence, and healthy volunteer trials. Part of the Novotech group.

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.