Adelaide, AU & North Carolina, USA, Mar 28, 2024 – (ACN Newswire) – Clinica Avance, 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.
"Este al nostru GlobalReady program și avem mai mult de 90 de clienți biotehnologii care profită de acest proces unic și simplificat în mai multe regiuni. Cu o strategie globalizată, asigurăm eficiența la fiecare pas”, a spus ea.
“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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Contact media:
Clinica Avance
[e-mail protejat]
Kate Thompson
Avance Clinical este cel mai mare CRO cu servicii complete premium din Australia și America de Nord, care oferă studii clinice de calitate, cu date acceptate la nivel global, în Australia, Noua Zeelandă și SUA pentru biotehnologii internaționali. Clienții companiei sunt biotehnologii care finalizează Faza I până la Faza III a programului lor de dezvoltare de medicamente, care necesită servicii de cercetare clinică rapidă, agilă și adaptabilă, orientată spre soluții.
Premiile Frost și Sullivan
Avance Clinical, un beneficiar Frost & Sullivan Asia-Pacific CRO Market Leadership Award în ultimii patru ani, furnizează servicii CRO în regiune de mai bine de 26 de ani.
Preclinic până la faza medie până la târzie
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.
Cu experiență în peste 120 de indicații, CRO poate oferi rezultate de clasă mondială și date de înaltă calitate acceptate la nivel internațional pentru revizuirea FDA și EMA.
Tehnologia
Avance Clinical folosește tehnologie de ultimă oră și sisteme standard de aur în toate domeniile funcționale pentru a oferi clienților cele mai eficiente procese. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta și Medrio sunt doar câțiva dintre partenerii tehnologici.
Subiect: Rezumatul comunicatului de presă
Sursa: Clinica Avance
Sectoare: Biotehnologie, Sănătate și farmacie, Studii Clinice
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