Country: Australia

About Avance Clinical Avance Clinical is the largest premium full-service Australian and US CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services. Frost & Sullivan Awards Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past three years, has been providing CRO services in the region for more than two decades. Pre-clinical through to Phase 1 and 2 Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review. Technology Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM Watson and Medrio are just some of the technology partners. www.avancecro.com | Avance Clinical is a full-service CRO for biotechs with a proven track-record for delivering clinical excellence in Australia, New Zealand, and North America. As the largest premium full-service CRO in Australia and North America, Avance Clinical specializes in delivering top-tier clinical trials that yield globally accepted data. Avance Clinical has been recognized for the fourth consecutive year by Frost & Sullivan in 2023, being awarded the Best Practices Customer Value Leadership for Biotech’s award, for its continuous exceptional performance. Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia and highly qualified sites and networks within the United States. With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable for FDA and EMA review. Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, Zelta, Veeva and Medrio are just some of Avance Clinical’s technology partners. www.avancecro.com | THE AUSTRALIA-BASED GLOBAL CRO FOR BIOTECHS Avance Clinical is a full-service Contract Research Organization (CRO) headquartered in Australia, with extensive operations across New Zealand, Asia, North America, and Europe. As the market leaders in Early Phase clinical trials, we leverage the unique advantages of the Australian market, including rapid ethics approval, no IND requirement, and the 43.5% R&D tax rebate, to provide biotechs with an accelerated pathway to clinical success. Specializing in world-class operations, we guide biotechs from early pre-clinical development through to late-phase studies. With a focus on agility, innovation, and cost-effectiveness, we deliver fast results backed by robust, globally accepted data. With expertise spanning over 250+ indications, across all therapeutic areas, over the last three decades, Avance Clinical consistently delivers data recognized by key global regulators, including the TGA, FDA, EMA, MHRA, MFDS, and PDMA. What sets us apart is our personalized service tailored to each client, ensuring customized, flexible solutions rather than a one-size-fits-all approach. | Avance Clinical is a leading, full-service Contract Research Organization (CRO) specialising exclusively in the delivery of high-quality clinical trial services for biopharmaceutical companies. With deep expertise across early- to late-phase clinical development, Avance Clinical partners with innovative biotech companies globally to accelerate the development of novel therapeutics. Founded in Australia, Avance Clinical is recognised for its strong scientific leadership, agile operating model, and consistent delivery of high-quality clinical trial data accepted by major global regulatory authorities, including the FDA and EMA. The company provides end-to-end clinical development services, including clinical operations, project management, regulatory affairs, biostatistics, data management, medical writing, pharmacovigilance, and biometrics, across a broad range of therapeutic areas. A key differentiator of Avance Clinical is its Centres of Excellence (CoEs) model, which embeds deep therapeutic and functional expertise across the organisation. These CoEs are designed to support complex clinical programs through specialised scientific leadership, proven operational execution, and consistent global quality standards. The Early Phase Centre of Excellence supports rapid transition from preclinical development into first-in-human and early clinical studies. Leveraging Australia’s favourable regulatory framework—where no IND is required and study start-up timelines can be as short as five to six weeks—this CoE provides integrated expertise in protocol design, regulatory strategy, clinical pharmacology, PK/PD, dose escalation, and early safety evaluation. Sponsors also benefit from Australia’s 43.5% R&D tax rebate on eligible clinical trial expenditure, delivering significant cost efficiencies while maintaining world-class quality. Avance Clinical’s Oncology Centre of Excellence delivers specialised support across solid tumours and hematological malignancies, with particular strength in early-phase oncology trials. This CoE brings together scientific leadership and operational expertise in complex study designs, including adaptive trials, biomarker-driven studies, and multi-regional oncology programs. The team works closely with leading investigators, specialist oncology sites, and key opinion leaders to ensure efficient study execution and high-quality, regulatory-ready data. The Central Nervous System (CNS) Centre of Excellence provides dedicated expertise across neurological and psychiatric indications. The CNS CoE supports trials requiring complex endpoint selection, specialised rating scales, and rigorous data quality oversight, with a strong focus on rater training, consistency, and patient safety. The team has experience across both early- and late-phase CNS programs, supporting sponsors through regulatory interactions and clinical execution. Avance Clinical’s Renal and Metabolic Centre of Excellence focuses on clinical development programs in kidney disease, metabolic disorders, and related systemic conditions. This CoE brings deep experience in managing trials with complex patient populations, comorbidities, and long-term endpoints. The team supports protocol design, patient recruitment strategies, biomarker integration, and global site engagement to ensure efficient delivery of renal and metabolic studies across regions. Complementing its therapeutic CoEs, Avance Clinical operates functional Centres of Excellence across Biostatistics, Data Management, Medical Writing, Pharmacovigilance, and Regulatory Affairs. These functional CoEs ensure consistency, quality oversight, and regulatory compliance across all programs, enabling scalable and efficient global trial delivery. Avance Clinical’s Australian operations provide a strategic advantage for early-phase and complex clinical trials, offering rapid start-up timelines, cost efficiencies, and access to highly experienced investigators and clinical sites. The company’s global footprint spans Australia, North America, Asia, and Europe, enabling seamless execution of regional and multi-regional clinical trials. North America represents Avance Clinical’s largest market outside Australia, supporting the majority of its biotech clients, while its Asia hub in Seoul, South Korea, provides access to Asia-Pacific patient populations and supports later-phase multi-regional development strategies. Led by an experienced executive and scientific leadership team with extensive backgrounds in drug discovery, clinical development, and regulatory strategy, Avance Clinical is recognised for its commitment to quality, transparency, and long-term partnerships. The company works as a true extension of its sponsors’ teams, delivering flexible, biotech-focused solutions tailored to the needs of emerging and mid-size biopharmaceutical companies. As a trusted CRO partner, Avance Clinical is dedicated to advancing innovative therapies from first-in-human through to late-stage development, helping biopharmaceutical companies bring new medicines to patients faster, more efficiently, and with confidence in the quality of their clinical data.