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North Carolina, USA & Adelaide, Australia, Apr 19, 2024 - (ACN Newswire) - Avance Clinical, the award-winning North American and Australian market-leading CRO for biotechs, will attend World Orphan Drug Conference in Boston (April 23-25, 2024) to share their rare diseases drug development expertise with biotechs (booth #730).Avance Clinical CEO, Yvonne Lungershausen said that Avance Clinical is dedicated to advancing research and ensuring faster access to therapies that can make a significant difference in patients’ lives.  “Avance Clinical has deep therapeutic knowledge of this area, completing over 50 trials in rare and orphan diseases globally in the last five years, including Fragile X Syndrome, Duchenne Muscular Dystrophy, Rett Syndrome and Erythropoietic Protoporphyria,” she said. Central to the company’s success in this sector is collaboration with disease-specific advocacy groups, patient registries, and tailored recruitment strategies, to enhance patient enrolment and retention.  Lungershausen said, “We have an extensive understanding of the unique challenges in managing small patient populations. Our patient-centric approach places patients at the heart of our operations, ensuring optimal care through the selection of experienced sites and clinics. “Avance Clinical engages with clients early in the planning process to tailor trial designs to accommodate the unique needs and challenges faced by patients with rare diseases, ultimately improving patient access to critical medicines,” she said. Avance Clinical is adept at crafting adaptive, patient-focused protocols that adhere to regulatory standards. The company’s innovative approach to study design, combined with over 26 years of experience in delivering FDA and EMA-quality data, positions Avance Clinical as a CRO capable of navigating the complexities of the regulatory landscape efficiently. Lungershausen describes Avance Clinical as a mid-sized, agile, and responsive CRO with a proven track record of swiftly advancing high-quality clinical programs. “This makes us an ideal CRO partner for rare disease-focussed biotechs,” she said.  “Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III,” she said. “This is our GlobalReady program and we have more than 90 biotech clients leveraging this unique, streamlined multi-region process. With a globalized strategy, we ensure efficiency every step of the way,” she said. “Biotechs are looking for a partner that can seamlessly help transition rapidly with high-quality data that is readily accepted by the FDA and other regulatory agencies. Our in-house global regulatory affairs team assists biotechs to navigate regulatory complexities with confidence and support our clients with FDA, EMA and TGA submissions,” she said. “In addition, our GlobalReady Site Partnership Network of over 1,250 highly qualified sites across the United States ensures maximum efficiency and effectiveness in our biotech’s clinical trials, particularly in rare and orphan indications,” she said. New analysis by market research leader Frost & Sullivan shows one of the major challenges for biotechs was finding the right biotech aligned CRO partner. “More than 60% of US biotechs experience delays seeking the right CRO partner to accelerate their drug development programs,” Lungershausen said. (See report here). The comprehensive report underscores the increasing biotech preference to collaborate with the right sized CROs that can accommodate the fast-paced nature of biotech demands. Executive Vice President, North America Operations, John Mann, will attend the conference in Boston alongside Avance’s team of clinical trial experts, including Senior Vice President, Scientific and Regulatory Affairs Kevin Leach and Director of Business Development Clint Henry.Visit Booth #730 to discuss your upcoming clinical trial, and find out more about the Avance Clinical Advantage, supporting biotechs globally in their clinical development programs.Book a meeting with the team here Find out more: Learn about the GlobalReady model here https://www.avancecro.com/avance-clinical-north-america-operations/   For more information about the benefits of running your next study with Avance Clinical contact us   Visit Booth #730 to discuss your drug development program at the World Orphan Drug Congress in Boston, April 23- 25 Media Contact:  Avance Clinical media@avancecro.com  Kate Thompson About Avance Clinical Avance Clinical is the largest premium full-service Australian and North American 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 completing Phase I to Phase III of their drug development program that requires 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 four years, has been providing CRO services in the region for more than 26 years. Pre-clinical through to mid to late phase Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical consultancy through to Phase III clinical services leveraging global reach, supported by significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 120 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, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners. www.avancecro.com  


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