Latest news with #AvanceClinical
Yahoo
26-05-2025
- Business
- Yahoo
Australia Delivers Certainty for US Biotechs in 2025: Avance Clinical Offers Fast Start-Up, Regulatory Predictability, and R&D Rebates
ADELAIDE, Australia, May 26, 2025 (GLOBE NEWSWIRE) -- As regulatory uncertainty grows in the United States, US biotechs are increasingly looking to Australia as a stable and predictable launchpad for early-phase clinical trials. With its globally accepted regulatory framework, accelerated timelines, and 43.5% R&D rebate, Australia offers a compelling advantage — and Avance Clinical, Australia's leading early-phase specialist CRO, is delivering the GlobalReady solution to help biotechs de-risk, conserve capital and accelerate their programs. 'In today's capital-constrained biotech environment, sponsors need solutions that deliver speed, predictability, quality, and capital efficiency,' said Ben Edwards, Chief Operating Officer at Avance Clinical. 'Australia is a smart strategic choice — it allows biotechs to start faster, control costs, reduce burn rate, and generate FDA-accepted data without the delays and complexity of the US IND process in a Phase I setting.' Through its GlobalReady program, Avance Clinical enables biotech sponsors to rapidly initiate early phase trials in Australia — often within 5 to 6 weeks — without the need for an open IND. The company's deep regulatory and scientific expertise ensures that data generated under the Australian Therapeutic Goods Administration (TGA) framework is accepted by the FDA and other major regulatory agencies worldwide. In addition to regulatory speed and data quality, Australia offers a unique fiscal advantage with its 43.5% R&D tax rebate, significantly reducing early clinical trial costs — a major incentive for venture-backed biotech companies managing limited runway. As part of its GlobalReady model, Avance Clinical also facilitates expansion into Asia, where its newly signed partnerships with leading Taiwanese and South Korean clinical sites offer biotechs access to large, treatment-naïve patient populations — essential for fast Phase II and III recruitment. For later-phase trials, Avance Clinical also provides a seamless expansion to its US-based operational and regulatory teams, ensuring continuity, quality oversight, and alignment with sponsor expectations throughout the development lifecycle. "Our model is built specifically for biotechs — agile, science-driven, capital efficient and globally integrated," said Edwards. "From Australia to Asia to the US, we provide a single CRO partner to guide clinical programs from first-in-human to regulatory submission." Avance Clinical will be showcasing its GlobalReady capabilities at two major US conferences: the 2025 ASCO Annual Meeting in Chicago, 30 May – 3 June, and BIO International 2025 in Boston, 16 – 19 June. To schedule a meeting with the team, please visit About Avance Clinical Avance Clinical is a leading full-service CRO offering biotech companies faster, more flexible, and higher-quality clinical trial services. Headquartered in Australia, Avance Clinical delivers globally accepted data across Australia, New Zealand, Asia, North America, and Europe. With over 30 years of experience and expertise in more than 250 indications, the company specializes in early to late-phase clinical trials, providing comprehensive support from pre-clinical consulting through to Phase I-II studies. Discover Avance Clinical's Australian Advantage and Asia Advantage Get into clinic faster with Avance Clinical's ClinicReady service Learn about Avance Clinical's GlobalReady model for biotechs Speak with our scientific experts about your upcoming study Book a meeting or request a proposal For media enquiries, email media@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
26-05-2025
- Business
- Yahoo
Australia Delivers Certainty for US Biotechs in 2025: Avance Clinical Offers Fast Start-Up, Regulatory Predictability, and R&D Rebates
ADELAIDE, Australia, May 26, 2025 (GLOBE NEWSWIRE) -- As regulatory uncertainty grows in the United States, US biotechs are increasingly looking to Australia as a stable and predictable launchpad for early-phase clinical trials. With its globally accepted regulatory framework, accelerated timelines, and 43.5% R&D rebate, Australia offers a compelling advantage — and Avance Clinical, Australia's leading early-phase specialist CRO, is delivering the GlobalReady solution to help biotechs de-risk, conserve capital and accelerate their programs. 'In today's capital-constrained biotech environment, sponsors need solutions that deliver speed, predictability, quality, and capital efficiency,' said Ben Edwards, Chief Operating Officer at Avance Clinical. 'Australia is a smart strategic choice — it allows biotechs to start faster, control costs, reduce burn rate, and generate FDA-accepted data without the delays and complexity of the US IND process in a Phase I setting.' Through its GlobalReady program, Avance Clinical enables biotech sponsors to rapidly initiate early phase trials in Australia — often within 5 to 6 weeks — without the need for an open IND. The company's deep regulatory and scientific expertise ensures that data generated under the Australian Therapeutic Goods Administration (TGA) framework is accepted by the FDA and other major regulatory agencies worldwide. In addition to regulatory speed and data quality, Australia offers a unique fiscal advantage with its 43.5% R&D tax rebate, significantly reducing early clinical trial costs — a major incentive for venture-backed biotech companies managing limited runway. As part of its GlobalReady model, Avance Clinical also facilitates expansion into Asia, where its newly signed partnerships with leading Taiwanese and South Korean clinical sites offer biotechs access to large, treatment-naïve patient populations — essential for fast Phase II and III recruitment. For later-phase trials, Avance Clinical also provides a seamless expansion to its US-based operational and regulatory teams, ensuring continuity, quality oversight, and alignment with sponsor expectations throughout the development lifecycle. "Our model is built specifically for biotechs — agile, science-driven, capital efficient and globally integrated," said Edwards. "From Australia to Asia to the US, we provide a single CRO partner to guide clinical programs from first-in-human to regulatory submission." Avance Clinical will be showcasing its GlobalReady capabilities at two major US conferences: the 2025 ASCO Annual Meeting in Chicago, 30 May – 3 June, and BIO International 2025 in Boston, 16 – 19 June. To schedule a meeting with the team, please visit About Avance Clinical Avance Clinical is a leading full-service CRO offering biotech companies faster, more flexible, and higher-quality clinical trial services. Headquartered in Australia, Avance Clinical delivers globally accepted data across Australia, New Zealand, Asia, North America, and Europe. With over 30 years of experience and expertise in more than 250 indications, the company specializes in early to late-phase clinical trials, providing comprehensive support from pre-clinical consulting through to Phase I-II studies. Discover Avance Clinical's Australian Advantage and Asia Advantage Get into clinic faster with Avance Clinical's ClinicReady service Learn about Avance Clinical's GlobalReady model for biotechs Speak with our scientific experts about your upcoming study Book a meeting or request a proposal For media enquiries, email media@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-05-2025
- Business
- Yahoo
Avance Clinical Honored with Frost & Sullivan's 2025 Global Customer Value Leadership Award for Transformative Biotech CRO Services
This award recognizes Avance Clinical's strategic innovation, operational agility, and unwavering commitment to client success in early-phase clinical trials. SAN ANTONIO, May 14, 2025 /PRNewswire/ -- Frost & Sullivan has named Avance Clinical the recipient of its 2025 Global Customer Value Leadership Award in the biotech contract research organization (CRO) sector, highlighting the company's outstanding performance in delivering exceptional client value through innovation, service excellence, and technology-enabled trial optimization. The accolade reinforces Avance Clinical's position as a trusted CRO partner that is uniquely equipped to support biotech sponsors navigating the complexities of early-phase research. Each year, Frost & Sullivan undertakes a comprehensive, independent analysis to benchmark companies on two core criteria—strategy alignment and execution effectiveness. Avance Clinical demonstrated clear leadership across both dimensions, offering a compelling combination of agility, scientific rigor, and digital innovation that continues to shape the biotech CRO landscape. According to Unmesh Lal, Vice President - Healthcare & Life Sciences at Frost & Sullivan, "Avance Clinical is positioning itself as a next-generation CRO with a deeply patient-centric and globally adaptive model. Under Yvonne Lungershausen's leadership, the company is striking a rare balance between innovation and regulatory rigor—leveraging technology to accelerate clinical trials while preserving scientific integrity. Their strategic focus on partnerships to drive global expansion, coupled with strong client retention and a commitment to quality, makes Avance a compelling player in the evolving biotech services landscape. Avance Clinical's growth strategy is built on its ability to anticipate and respond to market shifts, whether through digital transformation, data-driven decision-making, or strategic geographic expansion. The company's integration of artificial intelligence into core clinical operations—such as protocol development, medical writing, and workforce optimization—enables faster, more reliable outcomes for biotech innovators. By embedding intelligent automation into traditional manual workflows, Avance Clinical helps clients streamline study timelines while upholding the highest regulatory compliance and scientific integrity standards. These capabilities have positioned the company as a go-to CRO for sponsors seeking speed, quality, and flexibility in their clinical programs. Avance Clinical Chief Executive Officer, Yvonne Lungershausen said, "We are honored to receive this recognition from Frost & Sullivan, whose deep industry expertise and thoughtful analysis have been invaluable in highlighting what truly matters to our customers. At Avance Clinical, we are driven to be a smarter, faster, and more strategic partner for our clients because every patient deserves a future — that mission is at the heart of everything we do." Beyond its technical strengths, Avance Clinical distinguishes itself through a deeply customer-focused model. Through real-time milestone reviews, proactive risk mitigation, and transparent communication, the company fosters long-term client relationships built on trust, performance, and shared goals. Its structured project oversight, workforce training, and quality framework consistently drive high satisfaction and retention rates among biotech sponsors worldwide. Frost & Sullivan recognizes Avance Clinical's ability to translate strategic foresight into measurable impacts, supporting biotech sponsors as they navigate increasing regulatory scrutiny, financial pressures, and extended development timelines. The company's dedication to continuous improvement, global expansion, and collaborative innovation ensures its clients remain competitive in a fast-changing market. The Global Customer Value Leadership Award is one of Frost & Sullivan's highest honors, presented to organizations that elevate industry standards through breakthrough strategies and customer-centric delivery. Winners are selected based on demonstrated excellence in driving customer success, strengthening market standing, and translating strategic vision into scalable, high-impact outcomes. Frost & Sullivan's Best Practices Awards are the result of extensive independent research, comparing market participants on performance indicators such as growth strategy, innovation, customer engagement, and operational execution. The awards celebrate companies that have risen above the competition to deliver best-in-class results and set benchmarks for success across global industries. About Frost & Sullivan For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, megatrends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion. Contact: Tarini SinghE: About Avance Clinical Avance Clinical is a leading Contract Research Organization (CRO) offering biotech companies faster, more flexible, and higher-quality clinical trial services. As the largest premium full-service CRO headquartered in Australia, Avance Clinical delivers globally accepted data across Australia, New Zealand, Asia, North America, and Europe for international biotechs. With 30 years of experience and expertise spanning over more than 250 indications, the company provides comprehensive clinical research services from early to late-phase trials. Media Enquiries: media@ View original content to download multimedia: SOURCE Frost & Sullivan Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
14-05-2025
- Business
- Cision Canada
Avance Clinical Honored with Frost & Sullivan's 2025 Global Customer Value Leadership Award for Transformative Biotech CRO Services
This award recognizes Avance Clinical's strategic innovation, operational agility, and unwavering commitment to client success in early-phase clinical trials. SAN ANTONIO, May 14, 2025 /CNW/ -- Frost & Sullivan has named Avance Clinical the recipient of its 2025 Global Customer Value Leadership Award in the biotech contract research organization (CRO) sector, highlighting the company's outstanding performance in delivering exceptional client value through innovation, service excellence, and technology-enabled trial optimization. The accolade reinforces Avance Clinical's position as a trusted CRO partner that is uniquely equipped to support biotech sponsors navigating the complexities of early-phase research. Each year, Frost & Sullivan undertakes a comprehensive, independent analysis to benchmark companies on two core criteria—strategy alignment and execution effectiveness. Avance Clinical demonstrated clear leadership across both dimensions, offering a compelling combination of agility, scientific rigor, and digital innovation that continues to shape the biotech CRO landscape. According to Unmesh Lal, Vice President - Healthcare & Life Sciences at Frost & Sullivan, "Avance Clinical is positioning itself as a next-generation CRO with a deeply patient-centric and globally adaptive model. Under Yvonne Lungershausen's leadership, the company is striking a rare balance between innovation and regulatory rigor—leveraging technology to accelerate clinical trials while preserving scientific integrity. Their strategic focus on partnerships to drive global expansion, coupled with strong client retention and a commitment to quality, makes Avance a compelling player in the evolving biotech services landscape. Avance Clinical's growth strategy is built on its ability to anticipate and respond to market shifts, whether through digital transformation, data-driven decision-making, or strategic geographic expansion. The company's integration of artificial intelligence into core clinical operations—such as protocol development, medical writing, and workforce optimization—enables faster, more reliable outcomes for biotech innovators. By embedding intelligent automation into traditional manual workflows, Avance Clinical helps clients streamline study timelines while upholding the highest regulatory compliance and scientific integrity standards. These capabilities have positioned the company as a go-to CRO for sponsors seeking speed, quality, and flexibility in their clinical programs. Avance Clinical Chief Executive Officer, Yvonne Lungershausen said, "We are honored to receive this recognition from Frost & Sullivan, whose deep industry expertise and thoughtful analysis have been invaluable in highlighting what truly matters to our customers. At Avance Clinical, we are driven to be a smarter, faster, and more strategic partner for our clients because every patient deserves a future — that mission is at the heart of everything we do." Beyond its technical strengths, Avance Clinical distinguishes itself through a deeply customer-focused model. Through real-time milestone reviews, proactive risk mitigation, and transparent communication, the company fosters long-term client relationships built on trust, performance, and shared goals. Its structured project oversight, workforce training, and quality framework consistently drive high satisfaction and retention rates among biotech sponsors worldwide. Frost & Sullivan recognizes Avance Clinical's ability to translate strategic foresight into measurable impacts, supporting biotech sponsors as they navigate increasing regulatory scrutiny, financial pressures, and extended development timelines. The company's dedication to continuous improvement, global expansion, and collaborative innovation ensures its clients remain competitive in a fast-changing market. The Global Customer Value Leadership Award is one of Frost & Sullivan's highest honors, presented to organizations that elevate industry standards through breakthrough strategies and customer-centric delivery. Winners are selected based on demonstrated excellence in driving customer success, strengthening market standing, and translating strategic vision into scalable, high-impact outcomes. Frost & Sullivan's Best Practices Awards are the result of extensive independent research, comparing market participants on performance indicators such as growth strategy, innovation, customer engagement, and operational execution. The awards celebrate companies that have risen above the competition to deliver best-in-class results and set benchmarks for success across global industries. About Frost & Sullivan For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, megatrends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion. Contact: Tarini Singh E: About Avance Clinical Avance Clinical is a leading Contract Research Organization (CRO) offering biotech companies faster, more flexible, and higher-quality clinical trial services. As the largest premium full-service CRO headquartered in Australia, Avance Clinical delivers globally accepted data across Australia, New Zealand, Asia, North America, and Europe for international biotechs. With 30 years of experience and expertise spanning over more than 250 indications, the company provides comprehensive clinical research services from early to late-phase trials.
Associated Press
07-05-2025
- Business
- Associated Press
Avance Clinical Sponsors Prestigious Citeline Awards 2025 To Recognize Innovative Biotechnology Companies
ADELAIDE, Australia and BOSTON, May 07, 2025 (GLOBE NEWSWIRE) -- Avance Clinical, the award-winning, global CRO for biotechs, is proud to announce its sponsorship of the Citeline Awards 2025, to be held in Boston tomorrow, May 8, 2025. Recognized as a premier celebration of innovation and excellence in clinical R&D, the Citeline Awards honor the most significant achievements across the global biopharma industry. Now in its ninth year, the Citeline Awards attract leading biotechs, pharma innovators, and clinical research organizations. This year's categories include Excellence in Rare Disease Drug Development, Most Successful Early Phase Research (Preclinical & Phase I), and Clinical Research Team of the Year – Biotech, highlighting the leaders and organizations driving advancements in the sector. Avance Clinical's sponsorship reflects the company's commitment to supporting biotechs from early to late phase development across Australia, New Zealand, Asia, North America and Europe. With its proven GlobalReady program and agile biotech-focused model, Avance Clinical enables emerging biopharma companies to achieve accelerated development timelines, backed by world-class data accepted by global regulatory authorities including the FDA and EMA. Yvonne Lungershausen, CEO of Avance Clinical, said: 'As a company dedicated to partnering with innovative biotechs globally, we are honored to sponsor the Citeline Awards. These awards celebrate the spirit of innovation and excellence that drives our industry forward. We congratulate all the finalists for their extraordinary achievements and their commitment to advancing therapies that improve patient outcomes.' The Citeline Awards 2025 ceremony will take place at the Hyatt Regency Boston, in the Downtown Boston Theater District, bringing together top industry leaders, investors, and biotech pioneers for an evening of recognition and networking. For more information about the Citeline Awards 2025 and to view the full list of finalists and categories, visit Citeline Awards . About Avance Clinical Avance Clinical is a leading Contract Research Organization (CRO) offering biotech companies faster, more flexible, and higher-quality clinical trial services. As the largest premium full-service CRO headquartered in Australia, Avance Clinical delivers globally accepted data across Australia, New Zealand, Asia, North America, and Europe for international biotechs. With 30 years of experience and expertise spanning over more than 250 indications, the company provides comprehensive clinical research services from early to late-phase trials. Find out more: Media Enquiries: [email protected]
