--- title: "Global CRO Model for Biotech Drug Development | GlobalReady | Avance Clinical" description: "Your full-lifecycle global CRO model spanning early-phase clinical R&D in Australia, with pathways to North America, Asia Pacific, and Europe." canonical: "https://www.avancecro.com/cro/globalready/" generated: "2026-09-03T01:36:53+00:00" --- # Getting Biotechs **GlobalReady** Start in [Australia](https://www.avancecro.com/the-australian-advantage/), then seamlessly move to [North America](https://www.avancecro.com/the-north-american-advantage/), [Asia](https://www.avancecro.com/the-asia-advantage/) Pacific, and Europe without changing CROs or data standards. Every product development program is different. GlobalReady is built around yours. [Request A Proposal](https://www.avancecro.com/request-a-proposal/) ![](https://www.avancecro.com/wp-content/uploads/2026/07/Global-Network-USA-United-States-Of-America-North-America-Global-Business-Flight-Routes-aspect-ratio-1600-975-916x916.jpg) ## 30+ Years of Deep Clinical **Research Management** [Request A Proposal](https://www.avancecro.com/request-a-proposal/) ### 90+ GlobalReady Biotech Clients A proven model trusted by biotechs across every stage of development. ### Extending Budgets by up to 43.5% Secure the Australian Government R&D rebate on your clinical trial spend. ### Up to 5-6 Week Start-Up Site Initiation Visit and Study Start delivered faster than anywhere else in the world. ### Globally Accepted Data World-class data accepted by the FDA, EMA, TGA, and all major regulatory authorities. ### ![2026 Frost & Sullivan Global Biotechnology CRO Company of the Year](https://www.frost.com/wp-content/uploads/2026/05/FS_logo_wh_112524.webp) **2026 Global Biotechnology CRO Company of the Year** [Learn more](https://www.avancecro.com/news/frost-sullivans-2026-global-company-of-the-year/) ## **Global** Pathways No matter which regions your program touches, you’ll work with the same scientific and regulatory experts, the same data standards, and one integrated Avance Clinical team. From first-in-human planning through late-phase work, our direct operations and trusted global partner network mean your program can expand into new regions without handoffs or gaps in oversight. ![world-map-highlighted-white-v6-taller](https://www.avancecro.com/wp-content/uploads/2026/07/world-map-highlighted-white-v6-taller-1200x810.jpg) ## Where Does Your Program **Need To Go**? Every biotech’s journey is different. Below are the regional pathways available through GlobalReady, and what each one offers your program. [Australia](https://www.avancecro.com/the-australian-advantage/) is the strategic starting point for the GlobalReady model. No other market combines regulatory speed, cost efficiency, and globally accepted data generation the way Australia does. ### No IND required under Australia's Clinical Trial Notification (CTN) scheme ### Move from final protocol to study approval in as little as 5–6 weeks ### Up to 43.5% off clinical trial spend with the Australian Government R&D tax rebate ### ICH-GCP-compliant data accepted by FDA, EMA, and all major global regulatory bodies ### Specialized expertise in first-in-human and early-phase trials across 250+ indications [North America](https://www.avancecro.com/the-north-american-advantage/) is Avance Clinical’s largest clinical operations base outside [Australia](https://www.avancecro.com/the-australian-advantage/) and home to more than 80% of its biotech clients. ### End-to-end FDA regulatory submission and engagement support ### ClinicReady start-up expertise in-country ### Integrated in-house scientific and regulatory affairs team ### Dedicated scientific and regulatory experts in the U.S., with in-house depth in oncology and CNS therapeutic indications ### Seamless progression to Asia Pacific and Europe from North America Avance Clinical operates across multiple Asian markets, offering biotechs a fully integrated, multi-country clinical trial delivery model across the region. #### South Korea, Taiwan, Singapore, Malaysia, and India The [Asia](https://www.avancecro.com/the-asia-advantage/) Pacific hub is based in Seoul, South Korea. ### Large, diverse patient populations across multiple genetic backgrounds and disease profiles ### High prevalence of oncology, hepatitis, CNS, metabolic, and infectious diseases — faster recruitment for relevant indications ### Cost advantages vs. Western markets without sacrificing data quality ### Advanced digital health infrastructure across South Korea, Singapore, and Taiwan ### Streamlined regulatory environments across South Korea, Taiwan, Singapore, and Malaysia #### Mainland China Commercial representation in Shanghai and Beijing extends the GlobalReady model across the full APAC and China region. ### Direct access to China's rapidly growing biotech innovation ecosystem ### Large patient population scale with growing regulatory alignment through the NMPA ### Complements APAC operations for broad multi-regional late-phase coverage Avance Clinical’s GlobalReady model offers European biotechs a faster, more capital-efficient path to global clinical trials. ### Regulatory expertise spanning EMA, TGA, and all major global authorities. ### Proven across small molecules, monoclonal antibodies, ADCs, cell-based therapies, viral vector products, and nucleotide-based therapeutics ### Hybrid healthy volunteer/patient Phase I trial designs pioneered in Australia — maximizing early data value and setting Phase II up for success ### In-house therapeutic depth in Oncology, CNS, Renal, and Metabolic disorders ### 500+ clinical trials supported in the past five years across 250+ therapeutic indications ## Frequently Asked **Questions** Get answers to frequently asked questions about Avance Clinical’s GlobalReady offering. No. Australia’s Clinical Trial Notification (CTN) scheme means biotechs can begin [early-phase studies](https://www.avancecro.com/cro/phase-i-early-phase/) without an IND, saving up to a year in regulatory processing time and considerable costs. Avance Clinical has extensive experience with both the CTN and CTX schemes and can advise on which pathway fits your program. [Learn more about the Australian Advantage →](https://www.avancecro.com/the-australian-advantage/) Avance Clinical’s clients are currently experiencing a 3-week IRB/EC turnaround. From Site Initiation Visit to study start is typically achieved in 5-6 weeks, which is faster than anywhere else in the world. Yes. Avance Clinical generates ICH-GCP-compliant data accepted by all major regulatory authorities, including the FDA, EMA, TGA, MHRA, MFDS, and PDMA. See how Avance Clinical’s [global scientific and regulatory affairs team](https://www.avancecro.com/capabilities/global-scientific-regulatory-affairs/) manages this across regions. Biotechs conducting trials in [Australia](https://www.avancecro.com/the-australian-advantage/) can access up to 43.5% back on eligible clinical spend through the Australian Government’s R&D Tax Incentive, a non-dilutive source of funding that can extend across your development timeline. Yes, that’s the premise of GlobalReady. Biotechs can start [early phases in Australia](https://www.avancecro.com/cro/phase-i-early-phase/) and progress to [North America](https://www.avancecro.com/the-north-american-advantage/), [Asia](https://www.avancecro.com/the-asia-advantage/) Pacific, or Europe for [later phases](https://www.avancecro.com/cro/phase-ii-late-phase/) without changing CROs, teams, or data standards. With access to Avance Clinical’s trusted Centers of Excellence and multidisciplinary experts available for every program challenge, you walk away with globally accepted data and documentation. Avance Clinical has direct operations across [Australia](https://www.avancecro.com/the-australian-advantage/), New Zealand, and [North America](https://www.avancecro.com/the-north-american-advantage/), with established operations in South Korea and Taiwan — expanding into Singapore, Malaysia, India, and mainland China. European countries and site/patient recruitment are delivered through our growing team and/or trusted regional partners. [View all locations →](https://www.avancecro.com/locations/) GlobalReady supports programs across all major modalities — small molecules, monoclonal antibodies, ADCs, cell-based therapies, viral vector products, and nucleotide-based therapeutics — and across therapeutic areas including [Oncology](https://www.avancecro.com/therapeutic-areas/oncology/), [CNS](https://www.avancecro.com/therapeutic-areas/central-nervous-system-cns/), [Rare Disease](https://www.avancecro.com/therapeutic-areas/rare-disease-orphan-drug/), [Renal and Metabolic](https://www.avancecro.com/renal-cardiometabolic-center-of-excellence). ## Go Global. **Start in [Australia](https://www.avancecro.com/the-australian-advantage/)**. Talk to the Avance Clinical team about building a GlobalReady pathway for your program. [Request a proposal](https://www.avancecro.com/request-a-proposal/)