Avance Clinical Showcases Clinical Excellence at World Orphan Drug Conference in Boston, April 23-25
2024年4月19日 - 5:00PM
JCN 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 https://bit.ly/3U2fZi9
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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