Adelaide, AU & North Carolina, USA, Mar 28, 2024 – (ACN Newswire) – 前衛臨床, the award-winning Australian and North American market-leading CRO for biotechs, will attend World Vaccine Congress in Washington DC (April 1-4, 2024) and share the latest clinical trial client news including the Uvax Bio announcement. (Booth #267)
Avance Clinical CEO, Yvonne Lungershausen said the World Vaccine Congress was an important event for the company’s US and Australian teams as they continue to excel in biotech vaccine CRO services.
Lungershausen said Avance Clinical is 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 vaccine focussed biotechs,” she said. Lungershausen said the company has had significant vaccine client successes in infectious diseases, including COVID-19 and RSV, as well as other diseases such as Hypertension and Psoriasis.
She said Avance Clinical is proud to be working with many innovative vaccine biotech companies including Uvax Bio who have just announced another milestone in their Phase I HIV study. Mary Giffear, Uvax Bio’s Director of Clinical Operations reported, “we have completed enrollment in our Phase 1 study of the Company’s HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197, and the Australia-based trial is on schedule.”
Lungershausen said Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III.
“這是我們的 全球就緒 計劃，我們有 90 多家生物技術客戶正在利用這種獨特、簡化的多區域流程。憑藉全球化策略，我們確保每一步的效率。
“Biotechs are looking for a partner that can seamlessly help transition them with the ability to start fast with high-quality data that is readily accepted by the US Food and Drug Administration (FDA) and other regulatory agencies. Our in-house global regulatory affairs team assists biotechs to navigate regulatory complexities with confidence and work to 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,” she said.
Another key advantage for vaccine biotechs is that Avance Clinical is accredited as a gene technology CRO which allows it to manage pre-clinical and clinical trials for vaccines and GMO therapies.
The Office of the Gene Technology Regulator (OGTR) has developed globally compliant regulations and accreditations which are in line with international guidelines.
Avance Clinical’s Chief Scientific Officer Dr. Gabriel Kremmidiotis said: “This means that as an OGTR accredited CRO we can support our international biotech clients with extensive OGTR knowledge and experience to accelerate their clinical research. Indeed, we would argue the clarity around the OGTR regulations makes Australia one of the most attractive destinations for Cell and Gene Technology research,” he said.
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前衛臨床
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凱特·湯普森
Avance Clinical 是澳洲和北美最大的優質全方位服務 CRO，在澳洲、紐西蘭和美國為國際生技公司提供優質臨床試驗和全球認可的數據。該公司的客戶是完成藥物開發專案第一階段至第三階段的生物技術公司，該專案需要快速、敏捷和適應性的以解決方案為導向的臨床研究服務。
弗羅斯特沙利文獎
Avance Clinical 過去四年榮獲 Frost & Sullivan 亞太地區 CRO 市場領導獎，在該地區提供 CRO 服務超過 26 年。
臨床前至中後期
Avance Clinical 憑藉其經驗豐富的 ClinicReady 團隊提供從臨床前到 III 期臨床服務的臨床前服務，利用澳洲政府高達 43.5% 的激勵回扣和快速啟動監管流程。
CRO 擁有超過 120 種適應症的經驗，可以為 FDA 和 EMA 審查提供世界級的結果和國際公認的高質量數據。
專業技術
Avance Clinical 在所有職能領域中使用最先進的技術和黃金標準系統，為客戶提供最有效的流程。 Medidata、Oracle、TrialHub、Certinia、Salesforce、Zelta 和 Medrio 等只是部分技術合作夥伴。
主題：新聞發布摘要
資源： 前衛臨床
部門： 生物科技, 醫療保健與製藥, 臨床試驗
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