Clinical Trials
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- Revelation Biosciences has selected Avance Clinical as the contract research organization for its Phase 2/3 adaptive-design TITAN study evaluating Gemini in patients with acute kidney injury (AKI). - The study remains on track to begin later this year, according to Revelation's Chief Executive Officer James Rolke. - Gemini is Revelation's proprietary formulation designed to rebalance inflammation, with programs spanning AKI, chronic kidney disease, post-surgical infection prevention, and severe burn. - Avance Clinical launched a Renal and Cardiometabolic Center of Excellence in October 2025 to optimize recruitment and retention in complex kidney disease trials.
- Avance Clinical, a global full-service CRO headquartered in Australia, has appointed Liahna Toy as Senior Vice President & Head of Early Phase Center of Excellence to accelerate high-quality early-phase trials for emerging biotech sponsors. - The Early Phase Center of Excellence supports biotech sponsors from first-in-human through Phase I into Phase II trials, combining regulatory strategy, scientific leadership, clinical operations, biometrics, and pharmacovigilance services. - The center operates through a globally integrated model across Australia, New Zealand, the United States, the United Kingdom, South Korea, Taiwan and India, leveraging Australia's Clinical Trial Notification scheme and R&D Tax Incentive for cost-efficient development pathways.
- The early phase clinical trial outsourcing market is expected to grow from $9.53 billion in 2025 to $14.8 billion by 2030, representing a compound annual growth rate of 9.2%. - Personalized medicine is emerging as a central driver, with personalized therapies for rare diseases more than doubling from 6 in 2022 to 16 in 2023 according to the Personalized Medicine Coalition. - Key growth factors include adoption of decentralized trial methods, precision medicine focus, AI-enabled trial analytics, and increasing complexity of drug development pipelines. - North America currently holds the largest market share, while Asia-Pacific is anticipated to be the fastest-growing region during the forecast period.
- Avance Clinical, a global contract research organization, has acquired U.S.-based oncology specialist LumaBridge to strengthen its position in the largest and fastest-growing therapeutic area in global R&D. - The acquisition establishes Avance's global Oncology Center of Excellence and expands the company's U.S. footprint with enhanced medical, scientific, and regulatory expertise for complex cancer studies. - The combined organization will serve more than 50 biotechnology companies developing oncology therapies, offering an integrated pathway from Phase I studies in Australia and New Zealand through later-phase global programs. - LumaBridge brings experienced oncology leadership and proven capabilities in delivering complex cancer studies for global biotech and pharmaceutical clients across early and later phase clinical development.
- Avance Clinical launched a dedicated Early Phase Center of Excellence for Biotechs to address approval delays, slow site activation, and inefficient trial designs that increase costs and compromise data quality. - The center offers comprehensive services from assessing molecule suitability for healthy volunteers to designing adaptive clinical trial protocols that rapidly inform Phase II development. - The flagship ClinicReady program enables rapid study launches in Australia without IND requirements, providing accelerated access to cost-effective, high-quality clinical data. - The initiative leverages Avance Clinical's 30+ years of experience and proven Phase I unit partners to deliver globally accepted data while significantly reducing development timelines.
- Avance Clinical's GlobalReady program enables US biotechs to initiate early-phase trials in Australia within 5-6 weeks without requiring an open IND application. - Australia offers a 43.5% R&D tax rebate and TGA-approved data that is accepted by FDA and other major regulatory agencies worldwide. - The CRO has expanded into Asia through partnerships with Taiwanese and South Korean clinical sites to provide access to treatment-naïve patient populations. - Avance Clinical provides seamless transition capabilities from Australian early-phase trials to US-based later-phase operations for complete development lifecycle support.
- Avance Clinical, a global Contract Research Organization, has signed Memorandums of Understanding with four premier Taiwanese medical institutions, strengthening its GlobalReady model for biotech companies. - The partnerships with Taichung Veterans General Hospital, Taipei Medical University, China Medical University Hospital, and Kaohsiung Medical University Chung-Ho Memorial Hospital provide US biotechs access to Taiwan's advanced healthcare infrastructure and diverse patient populations. - This strategic expansion leverages Taiwan's regulatory efficiency and clinical expertise, particularly in areas like CAR-T cell immunotherapy, to accelerate innovative treatment development for patients worldwide.
- UK-based Simbec-Orion and Australian-headquartered Avance Clinical have signed a Memorandum of Understanding to create a unified global clinical research organization spanning Europe, Asia-Pacific, and North America. - The partnership combines Simbec-Orion's 50-year expertise in Clinical Pharmacology, Oncology, and Rare Diseases with Avance Clinical's 30-year track record across 250+ indications. - This strategic alliance enables seamless execution of global clinical trials from Phase I to III, offering clients expanded geographical reach and integrated research services while maintaining FDA and EMA data standards.
