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.
"Toto je naše GlobalReady a máme více než 90 biotechnologických klientů, kteří využívají tento jedinečný, efektivní multiregionální proces. Díky globalizované strategii zajišťujeme efektivitu na každém kroku,“ řekla.
“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.
"Více než 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
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Kontakt médií:
Avance Clinical
[chráněno e-mailem]
Kate Thompsonová
O společnosti Avance Clinical
Avance Clinical je největší prémiový full-service australský a severoamerický CRO poskytující kvalitní klinické studie s celosvětově uznávanými údaji v Austrálii, na Novém Zélandu a v USA pro mezinárodní biotechnologie. Klienty společnosti jsou biotechnologové dokončující fázi I až III svého programu vývoje léků, který vyžaduje rychlé, agilní a adaptivní služby klinického výzkumu orientované na řešení.
Frost & Sullivan Awards
Avance Clinical, držitel ocenění Frost & Sullivan Asia-Pacific CRO Market Leadership Award za poslední čtyři roky, poskytuje služby CRO v regionu již více než 26 let.
Preklinická až střední až pozdní fáze
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.
Díky zkušenostem s více než 120 indikacemi může CRO poskytovat prvotřídní výsledky a vysoce kvalitní mezinárodně uznávaná data pro hodnocení FDA a EMA.
Technika
Avance Clinical využívá nejmodernější technologie a systémy zlatého standardu ve všech funkčních oblastech, aby klientům poskytla ty nejefektivnější procesy. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta a Medrio jsou jen někteří z technologických partnerů.
Téma: Souhrn tiskové zprávy
Zdroj: Avance Clinical
Odvětví: Biotech, Healthcare & Pharm, Klinické Studie
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- Zdroj: https://www.acnnewswire.com/press-release/english/90368/
