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Biotech CRO Leader, Avance Clinical, Backs California Life Sciences Entrepreneurship Program With Gold Sponsorship

By Company News, Other newsNo Comments

Adelaide, Australia | North Carolina, USA – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, is proud to announce its gold sponsorship of California Life Sciences (CLS) Innovation and Entrepreneurship programming.

Liahna Toy, Vice President, Commercial Business Development at Avance Clinical, said the sponsorship was an ideal way of supporting early phase biotech companies in California.

“Avance Clinical has been delivering clinical drug development services for biotechs for FDA and EMA regulatory approval, for more than two decades, with a significant client base located in the US.

“CLS is a life sciences membership organization, supporting companies of all sizes, from early-stage innovators and startups to established industry leaders in the fields of biotech, pharmaceuticals, and medical technology.

“Avance Clinical is very proud to be a Gold Sponsor of CLS to support early phase biotechs by providing insights and education around the benefits of commencing their early phase, healthy volunteer studies in Australia and the benefit of our GlobalReady program which focuses on taking biotechs from Phase I in Australia through to later phase studies in the US,” she said.

About Avance Clinical

Avance Clinical is a full-service CRO for biotechs with a proven track-record for delivering clinical excellence in Australia, New Zealand, and North America. As the largest premium full-service CRO in Australia and North America, Avance Clinical specializes in delivering top-tier clinical trials that yield globally accepted data.

Award-winning CRO for Biotechs

Avance Clinical has been recognised for the fourth consecutive year by Frost & Sullivan in 2023, being awarded the Best Practices Customer Value Leadership award, for its exceptional performance.

Pre-clinical through to Phase I and Beyond

Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia.

With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable 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, Zelta, Veeva and Medrio are just some of Avance Clinical’s technology partners.

September 27, 2023
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Avance Clinical Appoints US-Based Executives – SVP Scientific And Regulatory Affairs, And Director Business Development

By Company News, New Team MembersNo Comments

Adelaide, Australia | Raleigh, North Carolina, USA – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, announces two key appointments in the US to support its continued global growth.

Kevin Leach joins as Senior Vice President of Scientific and Regulatory Affairs, based in Massachusetts, USA. Kevin has a background in the biopharma industry with experience in early and late-stage drug discovery and development.

Madison Esely-Kohlman has joined as a Director of Business Development based in Salt Lake City, Utah and is focused on partnering with biotech companies on their Phase I-III clinical trials.

In welcoming both Kevin and Madison, CEO, Yvonne Lungershausen said they bring significant expertise that will support Avance Clinical’s expanding US and Australian operations as well as our global growth plans.

“We are seeing increasing demand for our biotech-specific services such as ClinicReady and GlobalReady which are designed for pre-clinical, early phase and later phase clinical development. GlobalReady is a unique offering enabling biotechs to start rapidly and cost effectively with Avance Clinical in Australia and transition with our team in the US for later phase trials, with all the benefits of retaining the one CRO,” she said.

Kevin Leach PhD, DAB: Senior Vice President, Scientific and Regulatory Affairs

Kevin Leach has more than 20 years of experience working in drug discovery and development in the pharmaceutical industry and will provide exceptional knowledge and experience to Avance Clinical’s biotech clients. He has a PhD in biochemistry and molecular biophysics at Medical College of Virginia and completed his Post Doctoral Fellowship in Biological Engineering at Massachusetts Institute of Technology.

“Previously, I was on the client-side working with Avance Clinical. As we were considering the best CRO for our non-clinical and clinical programs Avance was consistently suggested to us as the premier partner in Australia. Once we started working together it was clear to me that the Avance team had a wealth of experience and expertise broadly in drug development and that we were in good hands at Avance.

“I joined Avance because I wanted to be part of an organization that was considered the gold standard in their field, and I felt comfortable that I would be working with highly intelligent, motivated, and experienced colleagues in our shared mission of bringing transformative medicines to patients.

“I am looking forward to applying my past experiences by working with the Avance team to enable sponsors developing diverse medicines of various molecular platforms, for different disease indications to deliver therapies that change and enrich the lives of the patients,” Kevin said.

Madison Esely-Kohlman: Director of Business Development

Madison Esely-Kohlman has considerable experience working in specialty drug development services, including in vitro DMPK testing and regulated bioanalysis, and GLP preclinical studies. Madison’s expertise includes engaging with clients early in their clinical development journey and supporting them into clinic. In her new role at Avance Clinical, she is looking forward to assisting clients navigate their clinical programs.

“Clinical trials bring not just tangible and thoroughly vetted medicines into the world; they can bring hope to families and individuals. Clinical trials run with expertise and efficiency mean faster access for those patients, and by joining Avance I am part of an organization dedicated to that outcome,” she said.

Madison is motivated by assisting US biotech companies to understand and take advantage of the benefits afforded by the Australian clinical pathway.

“A game-changer that really drew me to Avance Clinical as a CRO specifically is their ability to support sponsors in the longer term. The GlobalReady offering empowers our customers to maximize benefits of the Australian clinical network and transition into a global program with teams in the US and elsewhere in the world. My goal is to connect those companies to the resources and expertise available at Avance Clinical, so they have a trusted and capable partner in their programs,” Madison said.

Meet Madison in-person at COG West Coast on 7-8 November in Burlingame, CA.

 

About Avance Clinical

Avance Clinical is a full-service CRO for biotechs with a proven track-record for delivering clinical excellence in Australia, New Zealand, and North America. As the largest premium full-service CRO in Australia and North America, Avance Clinical specializes in delivering top-tier clinical trials that yield globally accepted data.

Award-winning CRO for Biotechs

Avance Clinical has been recognised for the fourth consecutive year by Frost & Sullivan in 2023, being awarded the Best Practices Customer Value Leadership for Biotech’s award, for its continuous exceptional performance.

Pre-clinical through to Phase I and Beyond

Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia. With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable 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, Zelta, Veeva and Medrio are just some of Avance Clinical’s technology partners.

September 21, 2023
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CEO Of Avance Clinical Nominated For Executive Of The Year In 2023 Citeline Pharma Intelligence Awards Japan

By Company Awards, Company NewsNo Comments

 

Adelaide, Australia | North Carolina, USA – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, is proud to announce that Chief Executive Officer Yvonne Lungershausen has been nominated for Executive of the Year in the 2023 Citeline Pharma Intelligence Awards in Japan.

The Citeline Pharma Intelligence Award will be announced on October 17, 2023 in Tokyo. According to Citeline, the award, “is designed to acknowledge excellence in leadership, career achievements, influence within the industry and the key characteristics that make a good leader, such as decisive and clear strategy, team building and employee welfare.”

Avance Clinical has achieved outstanding success guided by Yvonne’s leadership, global vision and passion for quality and customer service. The company’s staff numbers have grown significantly by approximately 85% since Avance was established in 2019. In the last 12 months, Avance Clinical expanded its operations into the US, opened a North Carolina office and a new biometrics hub in Bangalore, India.

With her experience of over three decades in the Australian, New Zealand and US clinical trials drug development environment Yvonne has not only put Avance Clinical on the global map but hired and retained some of the best talents from across the globe.

Yvonne has helped champion a culture of innovation and adaptability within the company -successfully embracing emerging technologies and capitalising on new market opportunities, hence strengthening its competitive position. Yvonne’s exceptional leadership has not only driven the company’s growth but has also positively impacted the lives of Avance Clinical’s employees, shareholders, and biotech clients.

She is highly regarded within the industry and is renowned for her exceptional expertise in addressing complex clinical trial challenges. She sees the importance of preparing for change fostering an adaptive and forward-thinking mindset within the organization. Her leadership is defined by a deep commitment to cultivating relationships and driving positive industry change.

CEO Yvonne Lungershausen said, “I am honoured to be nominated for this award. It reflects not only my accomplishments as leader of the organization but our entire team’s efforts at Avance Clinical globally. Our team’s dedication and commitment to quality clinical research is what makes us so successful. We take pride in servicing the needs of our biotech clients and providing them with the very best, customized solutions.

“I am looking forward to attending the Citeline Pharma Intelligence awards ceremony in Tokyo in October – there is also the added benefit of being able to meet with and connect with our regional biotech clients,” she said.

 

About Avance Clinical

Avance Clinical is a full-service CRO for biotechs with a proven track-record for delivering clinical excellence in Australia, New Zealand, and North America. As the largest premium full-service CRO in Australia and North America, Avance Clinical specializes in delivering top-tier clinical trials that yield globally accepted data.

Award-winning CRO for Biotechs

Avance Clinical has been recognised for the fourth consecutive year by Frost & Sullivan in 2023, being awarded the Best Practices Customer Value Leadership for Biotech’s award, for its continuous exceptional performance.

Pre-clinical through to Phase I and Beyond

Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia. With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable 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, Zelta, Veeva and Medrio are just some of Avance Clinical’s technology partners.

September 18, 2023
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Join Avance Clinical In Seoul At KoNECT Korea 2023

By Company News, Conference NewsNo Comments

Adelaide, Australia | North Carolina, USA – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, will visit Seoul in October to expand on collaborative opportunities with South Korean biotech companies. 

Avance Clinical’s delegation, including Chief Executive Officer Yvonne Lungershausen, Vice President, Commercial Business Development Liahna Toy, and Director of Business Development Cameron Williams, will participate in the prestigious KoNECT Korea Conference in Seoul, October 10-12 2023.

KoNECT Korea is a prestigious gathering of industry leaders, researchers, and innovators in the biotechnology and pharmaceutical sectors. This conference provides a unique platform for Avance Clinical to engage with South Korean biotech companies and experts, fostering collaborations and knowledge exchange.

Avance Clinical CEO Yvonne Lungershausen said they looked forward to expanding the company’s Korean client base and the opportunity to further establish and cultivate valuable relationships and connections with leading Korean biotech companies.

“We are looking forward to meeting with Korean biotechs to discuss the benefits of working with Avance Clinical,” commented Yvonne Lungershausen. “Korean biotechs can benefit from the Australian Advantage, which includes a fast start-up, no IND required, and up to 43.5% saving off clinical trial spend with the Australian R&D tax incentive.

“Korean biotechs then have access to the US via our US team based in North Carolina for later phase studies and ultimately FDA engagement,” she said.

“Avance Clinical’s Australian team has been supporting a number of Korean biotech companies through their clinical development programs offering a favourable regulatory environment, quality data, efficient processes, diverse patient populations, access to experts, stable political environment, strategic location, robust research infrastructure, and financial incentives. These factors collectively make Australia an attractive destination for biotech research and development.

“In fact, we are seeing increasing demand for our biotech specific services such as ClinicReady and GlobalReady which are designed for pre-clinical, early phase and later phase clinical development. GlobalReady is a unique offering enabling biotechs to start rapidly and cost effectively with Avance Clinical in Australia and transition with our team in the US for later phase trials, with all the benefits of retaining the one CRO,” she added.

Conference Information:

KoNECT Korea, October 10-12 2023 at the Conrad Hotel, Seoul, South Korea

https://www.avancecro.com/event/konect-korea/

Book a meeting with Avance Clinical:

https://www.konectintconference.org/web/Partnering/partneringRegistration.do

 

About Avance Clinical

Avance Clinical is a full-service CRO for biotechs with a proven track-record for delivering clinical excellence in Australia, New Zealand, and North America. As the largest premium full-service CRO in Australia and North America, Avance Clinical specializes in delivering top-tier clinical trials that yield globally accepted data.

Award-winning CRO for Biotechs

Avance Clinical has been recognised for the fourth consecutive year by Frost & Sullivan in 2023, being awarded the Best Practices Customer Value Leadership for Biotech’s award, for its continuous exceptional performance.

Pre-clinical through to Phase I and Beyond

Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia. With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable 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, Zelta, Veeva and Medrio are just some of Avance Clinical’s technology partners.

September 14, 2023
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Avance Clinical Earns Frost & Sullivan’s 2023 Best Practices Customer Value Leadership Award for Delivering High-quality Clinical Trials Based on Globally Accepted Data

By Company Awards, Company NewsNo Comments

Avance Clinical is an Australian and North American market-leading Contract Research Organization (CRO) that provides international biotechs with customized solutions. For the fourth consecutive year, Avance Clinical has been awarded Best Practices Customer Value Leadership awarded, by Frost and Sullivan, for its exceptional performance

San Antonio, TX — 7 August 2023 — Frost & Sullivan recently researched the Asia-Pacific biotechnology contract research organization industry and, based on its findings, recognizes Avance Clinical with the 2023 Customer Value Leadership Award. The company is a leading CRO with over 20 years of experience and provides comprehensive clinical research services to drug sponsors worldwide.

Avance Clinical’s services span the entire clinical trial process, from early-stage development to late-stage studies, supporting the ever-evolving demands of biotechnology research and development. It offers up-to-date strategic guidance on study design, regulatory compliance, and protocol development, ensuring trials comply with the rigorous requirements of regulatory authorities globally.

With its commitment to delivering first-class services, Avance Clinical has a strong track record of achievement in biotechnology research, and its unwavering devotion to quality has earned it a reputation as a trustworthy partner in pioneering biotech innovations. The company consistently forms strategic partnerships with leading academic institutions, research organizations, and clinical trial sites to gain access to innovative technologies and a network of experienced professionals. Through these partnerships, Avance Clinical incorporates the latest developments into its offerings and stays abreast of emerging biotechnology and clinical research trends.

“The company understands the intricacies of conducting clinical trials for innovative biopharmaceutical products, gene and cell therapies, and other advanced therapies. Its experts possess deep scientific knowledge and expertise in handling biotech’s clinical trial complexities, including specialized protocols, biomarker analysis, and pharmacokinetics/pharmacodynamics assessments,” said Azza Fazar, Best Practices Research Associate at Frost & Sullivan.

As a reflection of the tremendous value the company delivers to its customers, Avance Clinical’s flagship program, GlobalReady, has gained traction among biotech stakeholders. GlobalReady provides customers with substantial benefits, including time reduction, cost savings, and high-quality data generation, approved by the United States (US) Food and Drug Association (FDA).

Furthermore, with the newly opened North American headquarters in Wake Forest, North Carolina, Avance Clinical offers enhanced services in Australia, New Zealand, and the United States. The GlobalReady program streamlines the process and minimizes disruptions, cutting clinical trials’ time and cost by seamlessly facilitating the transition of early-to-late phase studies from customers in Australia and the US.

“The GlobalReady program has gained significant traction, embraced by over 50 biotech clients. In addition, the attractive 43.5% rebate on clinical spending in Australia allows the company’s clients to utilize its expertise and team in North America while maintaining services in Australia. This strategic approach enables clients to maximize rebate potential while leveraging Avance Clinical’s North American operations knowledge and capabilities,” noted Umesh Lal, Industry Analyst at Frost & Sullivan. With its strong overall performance, Avance Clinical earns Frost & Sullivan’s 2023 Customer Value Leadership Award in the Asia-Pacific biotechnology contract research organization industry.

Each year, Frost & Sullivan presents this award to the company that demonstrates excellence in implementing strategies that proactively create value for its customers, focusing on improving the return on the investment that customers make in its services or products. The award recognizes Avance Clinical for its unique focus on augmenting its customers’ value, beyond simply good customer service, leading to improved customer retention and customer base expansion.

Frost & Sullivan Best Practices Awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.

About Frost & Sullivan

For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, Mega Trends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success.

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 in their drug development phases that need fast, agile, and adaptive solution-oriented clinical research services.

Pre-clinical through to Phase I and Beyond

Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia.

With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable 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, Zelta, Veeva and Medrio are just some of Avance’s technology partners.

www.avancecro.com

August 7, 2023
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Avance Clinical Opens New North American Headquarters

By Company NewsNo Comments

Adelaide, Australia | North Carolina, USA – Avance Clinical the leading award-winning Australian and North American biotech CRO that offers the GlobalReady program to speed up the path to regulatory approval, has opened new North American headquarters in Wake Forest, North Carolina.

Avance Clinical expanded operations in the US last year to offer its clients a seamless drug development journey from Australia to the US with the same CRO.

Avance Clinical CEO Yvonne Lungershausen (3rd from right) and Executive Vice President, North American Operations, John Mann (2nd from right) celebrate the opening of the new US office with team members.

Avance Clinical is the largest and most established full-service Australian and New Zealand CRO with a proven track-record of data acceptance by the FDA and all other major regulatory bodies.

Avance Clinical’s Executive Vice President, North American Operations, John Mann, said he was proud to launch the company’s new North American headquarters.

“Avance Clinical has a fantastic reputation within the biotech industry and I am pleased that we have selected North Carolina for our North American headquarters.

“The Research Triangle Area (Raleigh, Durham, and Chapel Hill) is home to more than 600 life science companies.

The North America team will significantly increase in size over the next 12 months and this prime location will support that growth.”

Avance Clinical CEO Yvonne Lungershausen recently travelled to North Carolina to officially open the new office and welcome new staff members.

“Our North America operations offer our biotech clients conducting their early phase studies in Australia and New Zealand a seamless journey into the US to continue their clinical development programs, retaining the same high-quality CRO, which reduces time and cost and delivers quality FDA accepted data.

More than 50 biotech clients are now taking advantage of our GlobalReady program.

This GlobalReady model is designed to extend biotechs’ investments so they can achieve greater clinical development milestones with reduced spend, all with the assurance of FDA-accepted data.

In addition, the attractive 43.5% rebate on clinical spend in Australia, offers our clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximise their rebate potential.

We often point to the fact that there are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which again demonstrates Australian data acceptability with the FDA and other major regulatory authorities.

Our North America operations team has deep industry experience across a broad range of therapeutic areas, in particular Oncology, Central Nervous System (CNS) and Rare Diseases.

In addition, the world-class best practice technologies, systems and processes are integrated across all regions,” she said.

The Avance Clinical team offers exceptional study approval and success rates which can be attributed to its deep scientific expertise, advanced data technologies, knowledge of the Australian, New Zealand and North American regulatory environment, and its extensive relationships with sites and KOLs.

The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which allows it to manage pre-clinical and clinical trials for vaccines and GMO therapies.

Avance Clinical is at the cutting edge of clinical trial technology and has recently been ranked as the world leader in DCT technology adoption by GlobalData and Clinical Trial Arena in the CRO sector.

The report found 46% of Avance Clinical’s trials incorporated some elements of DCT technologies in 2022 including telemedicine, remote monitoring, and digital data collection.

The DCT report also noted that Avance Clinical’s staff training in the latest technologies was a key factor in the ranking. See the full report here

Avance Clinical has achieved high growth and industry-leading repeat business rates with its focus on gold-standard technology paired with solution-orientated clinical experts. This is the mix that biopharma clients clearly require in this fast-moving, competitive, and high-stakes sector.

June 29, 2023
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Avance Clinical at ASCO & BIO 2023: Early Phase Oncology Trials Increasingly Elaborate and Demand More Patients

By Company News, Conference NewsNo Comments

Adelaide, Australia | San Diego, USA – Avance Clinical the leading award-winning Australian and North American CRO that offers ClinicReady and GlobalReady for early-phase biotech companies to speed up the path to regulatory approval, says early-phase oncology studies are increasingly more complex and demand more patients.

Avance’s ClinicReady and GlobalReady service platforms offer significant benefits to product development in oncology.

Book a meeting with Avance Clinical at ASCO

Book a meeting with Avance Clinical at BIO Booth #2884

According to Avance Clinical’s Chief Scientific Officer Gabriel Kremmidiotis who is part of the Avance Clinical team attending ASCO:

“Recently, Phase I clinical trial designs in Oncology patients have become more elaborate and include elements of dose escalation, dose expansion, and assessment of drug combinations.

This, in addition to the increasing number of new emerging therapeutics, has increased the demand for fast progress through the early phases of development and a greater demand for access to patients.

Utilizing Australia’s regulatory environment and high-quality oncology experts, Avance Clinical is able to facilitate a fast project launch and seamless transition across different parts of modular oncology protocol designs.

Studies start in Australia and, at appropriate stages, expand to the US as determined by patient accrual number requirements for each study.

Retaining the majority of backend services (biostatistics, data management, pharmacokinetics and medical writing) in Australia ensures the highest degree of financial benefit for our clients through the Australian R&D tax incentive.”

Avance Clinical CEO, Yvonne Lungershausen, Chief Scientific Officer Gabriel Kremmidiotis, and Head of Scientific and Regulatory Affairs Jorgen Mould are featured in a new Global Health video on Reuters news service about the importance of quality clinical trials as part of the drug development process.

The Global Health program brings together 100 leaders and executives from various sectors of the Private and Public Healthcare Industry.

Avance Clinical CEO, Yvonne Lungershausen and Executive VP North American Operations John Mann attended the Global Health Summit and Yvonne was a leading panelist.

Avance Clinical is at the cutting edge of clinical trial technology and has recently been ranked as the world leader in decentralized clinical trials (DCT) technology adoption by GlobalData and Clinical Trial Arena in the CRO sector.

The report found 46% of Avance Clinical’s trials incorporated some elements of DCT technologies in 2022 including telemedicine, remote monitoring, and digital data collection.

The DCT report also noted that Avance Clinical’s staff training in the latest technologies was a key factor in the ranking. See the full report here

Avance Clinical’s unique GlobalReady offering enables biotechs that have completed early phase trials in Australia to rapidly and seamlessly transition to the US in preparation for FDA approvals, all with the one CRO and dedicated teams across both regions, which reduces time and cost and delivers quality data.

There are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which demonstrates Australian data acceptability with the FDA and other major regulatory authorities.

More than 40 biotech clients are now taking advantage of Avance Clinical’s GlobalReady program.

This seamless GlobalReady journey is designed so biotechs can:

  • Take advantage of the Australian early-phase clinical trial landscape (No IND and 43.5% tax rebate)                   
  • Transition or expand into North America for later phases – without changing CROs (retain study knowledge and processes/team)
  • Seamlessly operationalize global dose-escalation and dose-expansion trials across the two regions
  • Harness significant speed and cost advantages
  • Be assured of quality data – transferable and readily acceptable by the FDA and other regulatory authorities

Find out more:

Learn about the Australian Advantage here 

For more information about the benefits of running your next study with Avance Clinical

contact us: enquiries@avancecro.com

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 in their drug development phases that need 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 three years, has been providing CRO services in the region for more than 24 years.

Pre-clinical through to Phase I and Beyond

Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia.

With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable 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, Zelta, Veeva and Medrio are just some of Avance’s technology partners.

www.avancecro.com

May 30, 2023
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Avance Clinical Joins Global Health Summit Campaign for Faster Access to Life-Changing and Life-Saving Therapies

By Company Awards, Company NewsNo Comments

Adelaide, Australia | San Diego, USA – Avance Clinical the leading award-winning Australian and North American CRO that offers the programs ClinicReady and GlobalReady for early-phase biotech companies to speed up the path to regulatory approval, has been invited to join the Global Health Summit campaign which will be featured on Reuters.

Avance Clinical CEO, Yvonne Lungershausen, Chief Scientific Officer Gabriel Kremmidiotis, and Head of Scientific and Regulatory Affairs Jorgen Mould are interviewed in a new Global Health video featured on Reuters news service about the importance of quality clinical trials as part of the drug development process.

The campaign is a collection of interviews and video documentaries, highlighting international business leaders and healthcare specialists from various industries. The series will showcase organisations spearheading specific health initiatives, developing ground-breaking medicine and complex health technologies, and taking on the challenges of both physical and mental health globally.

The Global Health program launches at the upcoming Global Health Summit on 25-27 May 2023 at the prestigious Intercontinental Hotel in Geneva, bringing together 100 leaders and executives from various sectors of the Private and Public Healthcare Industry.

The event will feature round table discussions where participants will discuss strategies, share knowledge and expertise, and identify opportunities for collaboration. This will be complemented by keynote speeches and panel discussions that will explore the latest trends and emerging issues in the healthcare industry.

Avance Clinical CEO, Yvonne Lungershausen and Executive VP North American Operations John Mann will be attending the Global Health Summit and Yvonne will be a leading panelist.

Avance Clinical is at the cutting edge of clinical trial technology and has recently been ranked as the world leader in DCT technology adoption by GlobalData and Clinical Trial Arena in the CRO sector.

The report found 46% of Avance Clinical’s trials incorporated some elements of DCT technologies in 2022 including telemedicine, remote monitoring, and digital data collection.

The DCT report also noted that Avance Clinical’s staff training in the latest technologies was a key factor in the ranking. See the full report here

Avance Clinical’s unique clinical offering GlobalReady enables biotechs that have completed early to mid-phases in Australia to rapidly and seamlessly transition to the US in preparation for FDA approvals, all with the one CRO and dedicated teams across both regions, which reduces time and cost and delivers quality data.

There are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which demonstrates Australian data acceptability with the FDA and other major regulatory authorities.

More than 40 biotech clients are now taking advantage of Avance Clinical’s GlobalReady program.

This seamless GlobalReady journey is designed so biotechs can:

  • Take advantage of the Australian early-phase clinical trial landscape (No IND and 43.5% tax rebate)                   
  • Transition or expand into North America for later phases – without changing CROs (retain study knowledge and processes/team)
  • Seamlessly operationalize global dose-escalation and dose-expansion trials across the two regions
  • Harness significant speed and cost advantages
  • Be assured of quality data – transferable and readily acceptable by the FDA and other regulatory authorities

Find out more:

Learn about the Australian Advantage here 

Learn about the ClinicReady model here

Learn about the GlobalReady model here

or more information about the benefits of running your next study with Avance Clinical

contact us: enquiries@avancecro.com

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and US 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 in their early phases of drug development that need 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 three years, has been providing CRO services in the region for more than 24 years.

Pre-clinical through to Phase 1 and 2

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 110 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, IBM Watson and Medrio are just some of the technology partners.

www.avancecro.com

Media Contact:

Avance Clinical

media@avancecro.com

Kate Thompson

May 25, 2023
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