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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.

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.

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.

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.

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

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.

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

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

Avance Clinical CEO Joins Global BioPharma Panel for Evolution Europe Summit 2023

By Company News, Conference NewsNo Comments

Adelaide, Australia | San Diego, USA – Avance Clinical the leading award-winning Australian and North American biotech CRO that offers a GlobalReady program to early-phase biotech companies to speed up the path to regulatory approval, has been invited to join the Evolution Europe Summit 2023 (Montreux, Switzerland 20 April – 21 April 2023). The panel discussion is focused on the evolution of clinical trials including technology, DCTs, reducing time and cost, drug development planning for approvals, and scaling globally in later phases.

Avance Clinical CEO, Yvonne Lungershausen has been invited to share the Australian and US CRO experience and future projections with a focus on patient-centricity and Decentralized Clinical Trials (DCTs) at the Evolution Europe Summit 2023.

Avance Clinical was recently identified by GlobalData as a global leader in DCT technology.

The Evolution Summit is an invitation-only, premium forum bringing leading clinical research executives and innovative solution providers. The summit’s content is aligned with key clinical R&D challenges and interests, relevant market developments, and practical and progressive ideas and strategies adopted by successful pioneers. See full details here

Avance Clinical 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 GlobalReady model 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 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

Avance Clinical Leads DCT Technology Adoption Globally

By Company News, In the NewsNo Comments

Adelaide, Australia, North Carolina, USA – GlobalData and Clinical Trial Arena have identified Avance Clinical as the global leader in Decentralized Clinical Trial (DCT) technology adoption with 46% of their trials incorporating 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 DCT technologies was a key factor in the ranking. See the full report here

Avance Clinical which is globally recognized for quality data, delivers cost and time benefits for clinical-stage biotechs. The company’s GlobalReady model supports biotech clinical development from early to late phase across Avance Clinical’s operations in Australia, New Zealand, and North America.

More than 280 Phase III global biotech have conducted their Phase I study in Australia and then expanded globally, which demonstrates the quality of Australian data with the FDA and other major regulatory authorities.

According to the report:

“Clinical Trials Arena has established an exclusive taxonomic approach that involves reviewing thousands of drug trial public records from 2022 that mentioned decentralisation terminology in the study protocols, as curated in the Clinical Trials Database by GlobalData, the parent company of Clinical Trials Arena. Decentralisation terminology includes DCT elements such as telemedicine, remote monitoring, digital data collection, and more.”

Priya Nair, senior clinical trial analyst at GlobalData said this was a rapidly growing offering in CRO. “The US has a massive push to use DCTs because the FDA guidance wants more diversity in trials, and diversity goes hand in hand with DCTs,” she explained.

Avance Clinical CEO Yvonne Lungershausen, said Avance Clinical uses the full range of eClincial technologies including ePro, eSource  and eConsent to support biotech clinical trials.

“Having an expert team trained in the latest technologies is key to success for a CRO working across regions with multiple regulatory authorities and requirements.”

“DCT elements are being incorporated in trials to further manage biotech time and budget challenges and to offer diverse and remote patient populations access to clinical trials,” said Lungershausen.

The pandemic has been the catalyst in speeding up the adoption of decentralised clinical trial methods including home-based and remote monitoring options.

There are considerable benefits to DCT’s including:

  • Reduce the scheduling and travel burden on patients
  • Providing care from the comfort of the patient’s home
  • Connecting patients to trials on a global scale – patients that were otherwise inaccessible under more traditional trial protocols are now available

Advances in artificial intelligence (AI), machine learning, cloud computing, and blood self-collection devices are all revolutionizing the decentralized clinical trial process.

  • Wearable devices are demonstrating enormous potential whether worn as a wrist strap or as an adhesive patch on the body.  AI-embedded capabilities allow these devices to measure a patient’s heart rate or metabolism remotely. Linked to the cloud through secure networks, clinicians can receive and analyse the data in real-time.
  • Video calling and electronic reminders, can improve patient compliance in trials – prompting participants to take their medication at the right time or to record in their electronic diary development.
  • Technologies are developing to allow patient-centric sampling (self-collection of specimens) with devices that require either the use of a lancet or a finger prick whereas others do not, making clinical trials even more convenient.

Find out more:

  • Learn about the Australian Advantage here 
  • Learn about the GlobalReady model here
  • For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com

Enveric Biosciences Selects Australian CRO, Avance Clinical, in Preparation for Phase 1 Study of EB-373

By Client News, Company NewsNo Comments

EB-373, a proprietary psilocin prodrug, is on track to start its first-in-human clinical trial in the fourth quarter of 2023

CAMBRIDGE, Mass. –
Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, today announced that it has entered into an agreement with Avance Clinical, an Australia-based contract research organization (CRO) with US operations, for its planned Phase 1 clinical trial of EB-373, the company’s lead candidate targeting the treatment of anxiety disorders. The Phase 1 clinical trial is expected to initiate in the fourth quarter of 2023.

Under the agreement, Avance Clinical will manage the Phase 1 clinical trial of EB-373 in coordination with Enveric’s newly established Australian subsidiary, Enveric Therapeutics Pty, Ltd. The Phase 1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability of EB-373. EB-373, a next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia’s Therapeutic Goods Administration (TGA) and is currently in preclinical development targeting the treatment of anxiety disorder.

“With our Australia subsidiary established, we are actively preparing to initiate the planned Phase 1 trial of EB-373 and are pleased to have Avance Clinical as our CRO partner, given the company’s proven expertise and experience managing early-stage clinical programs in Australia,” said Joseph Tucker, Ph.D., Director and CEO of Enveric Bioscience. “EB-373 has the potential to bring much-needed innovation to the treatment of anxiety disorder, which is underserved by current therapeutic options. We are eager to evaluate the potential of EB-373 in this first-in-human Phase 1 clinical trial as an initial step towards building a broader pipeline of proprietary psilocin prodrugs and other innovative, psychedelic-inspired compounds for a range of mental health conditions.”

“We are excited to work with Enveric and are eager to leverage the expertise we’ve gained from managing early-stage clinical programs in Australia to empower the development of EB-373,” said Yvonne Lungershausen, Avance Clinical CEO. “We look forward to being a valued partner to Enveric in the execution of the EB-373 clinical program and ensuring the highest quality data is generated to support global regulatory filings.”

About EB-373

Enveric’s lead drug candidate, EB-373, is a New Chemical Entity (NCE), designed as a next-generation proprietary psilocin prodrug and developed leveraging its Psybrary™ drug discovery platform to target anxiety disorders. In preclinical studies, EB-373 interacted effectively with different types of serotonin receptors, including the serotonin 5-HT2A receptor resulting in the induction of the characteristic head twitch response in mice. In an animal behavioral model of anxiety, the Marble Burying Test in chronically stressed mice, EB-373 was able to promptly rescue the rate of marble burying on day 1 in line with the control rate at baseline, with lasting benefits up to the end of the experiment 7 days post-dose.

About Enveric Biosciences

Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders. Leveraging its unique discovery and development platform, The Psybrary™, Enveric has created a robust Intellectual Property portfolio of New Chemical Entities for specific mental health indications. Enveric’s lead program, EB-373, is a next-generation prodrug of psilocin, the active metabolite of psilocybin. EB-373 is the lead drug candidate from the EVM201 Series, currently advancing through preclinical development to treat anxiety disorders. Enveric is also advancing its third generation of therapeutics, the EVM301 Series, which aims to eliminate the psychedelic experience and remove unwanted effects, reduce safety concerns, and offer a novel and holistic approach to treating central nervous system disorders. Enveric is headquartered in Naples, FL, with offices in Cambridge, MA, and Calgary, AB, Canada. For more information, please visit www.enveric.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 that need fast, agile, and adaptive solution-oriented clinical research services. For more information, please visit www.avancecro.com.

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,”” expects” or “does not expect,” “proposed,” “is expected,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of not purely historical statements, including any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to successfully spin-off its cannabinoid assets; the ability to achieve the value creation contemplated by technical developments; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission (SEC), including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations

Tiberend Strategic Advisors, Inc.

Daniel Kontoh-Boateng

(862) 213-1398

dboateng@tiberend.com

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

cmcdonald@tiberend.com

Avance Clinical Appoints North America SVP with Global Contract Research Organization, Data Quality and DCT Expertise

By Company News, New Team MembersNo Comments

Adelaide, Australia | San Diego, USA – Avance Clinical the leading award-winning Australian and North American biotech CRO that offers the GlobalReady program for biotech companies to speed up the path to regulatory approval, today announced the appointment of John Mann as Senior Vice President, North America Operations.

John Mann has over 24 years of working in CROs and 15 years of experience working in senior leadership roles including Quintiles (now IQVIA), INC Research (now Syneos Health), PRA Health Sciences, and ICON. He has worked across a diverse range of therapeutic areas and business groups, most recently as Vice President of Emerging Biotech and Rare Disease Operations, and Vice President of Decentralized Clinical Trials (DCTs) Operations at ICON.  

John Mann will lead a team of more than 30 clinical trial specialists in North America and report to the CEO, Yvonne Lungershausen.

 “John has a passion for quality and process improvement, leading people, project management, and change management within clinical operations, and is well placed to support the team and our biotech clients to achieve drug development success in North America,” said Yvonne Lungershausen.

She said: “Importantly John also brings the latest DCT technology and operations experience which offers cost and time benefits for our biotech clients.”

Avance Clinical 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

John Mann said he was “extremely pleased to join such a world-class CRO with decades of experience and an exceptional reputation among US biotechs for early to late phase trials”.

“I am looking forward to applying my skills and knowledge in US-based global clinical trials as well as DCT enablement to support the biotech community which is increasingly under pressure to deliver results in a tough financial environment,” he said.

See more about John’s expertise here

“The US team is attracting biotechs wanting an experienced CRO that can deliver locally conducted trials with the highest reputation for quality data, outstanding site relationships, and rapid timelines,” commented Yvonne Lungershausen.

Avance Clinical’s 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 GlobalReady model 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 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

Avance Clinical Expands Biometrics Team into India to Support Biotech Trials Demand in US and Australia

By Company News, We are hiringNo Comments

Award-winning CRO Avance Clinical, which currently has the largest Biometrics team in Australia, is expanding further with global hires and a specialist hub in Bangalore, India to support growing demand.

Avance Clinical Director Biometrics Paul Donnelly said: “India has an exceptional reputation for biometrics specialists, in particular Statisticians and Statistical Programmers, and Bangalore is very much a centre for world-class biometrics talent.”

“Our biometrics team ensures biotech clinical research is regulatory ready for agencies like the FDA and the EMA, and so we need the best. This is therefore an obvious choice to supplement our Australian team of more than 60 biometrics experts with new colleagues in India,” he said.

Avance Clinical has been developing Biometrics expertise globally, with team members joining from South Africa, UK, Taiwan and US, all collaborating as one team.

Avance Clinical has been ranked as the global leader in Decentralized Clinical Trial (DCT) technology adoption by GlobalData and Clinical Trial Arena. 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 DCT technologies was a key factor in the ranking. See the full report here

Avance Clinical which is globally recognized for quality data, delivers cost and time benefits for clinical-stage biotechs. The company’s GlobalReady model supports biotech clinical development from early to late phase across Avance Clinical’s operations in Australia, New Zealand, and North America.

More than 280 Phase III global biotech have conducted their Phase I study in Australia and then expanded globally, which demonstrates the quality of Australian data with the FDA and other major regulatory authorities.

Avance Clinical CEO Yvonne Lungershausen, said:

“Having an expert team trained in the latest technologies is key to success for a CRO working across regions with multiple regulatory authorities and requirements.”

Find out more:

  • Learn about our Biometrics services here
  • Learn about the Australian Advantage here 
  • Learn about the GlobalReady model 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 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.

GlobalReady 

GlobalReady gives 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.

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.

“Avance Clinical remains a trusted partner, earning a reputation for delivering the overall best in the CRO industry. With its strong overall performance, Avance Clinical earns Frost & Sullivan’s 2022 Asia-Pacific Customer Value Leadership Award in the contract research organization industry.” Frost & Sullivan

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.

Avance Clinical Celebrates GlobalReady Success as More Than 40 Biotechs Enter Program

By Company NewsNo Comments

More than 40 biotech clients are now taking advantage of Avance Clinical’s GlobalReady program which delivers streamlined clinical development from early phase in Australia expanding to sites in North America for later phases. All with the one CRO and dedicated teams across both regions.

Avance Clinical made the announcement at Biotech Showcase 2023 where the team is available for meetings via PartnershipOne.

“Given this successful early adoption of GlobalReady we are expecting more than half of our biotech clients to join the program within the next six months, said Avance Clinical CEO Yvonne Lungershausen.

GlobalReady biotech clients are primarily biotechs from the US and Asia, with an increasing number expected from Europe over the next few months.

Avance Clinical is the leading Australian-based biotech CRO with US operations, which has been recognized by Frost & Sullivan for the past 3 years with the prestigious CRO Leadership Award.

CEO Yvonne Lungershausen said:

“These biotech clients are already benefiting from our expansion into North America and GlobalReady.

The 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.

GlobalReady gives 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.

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 maximize 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.”

This seamless GlobalReady journey is designed for success whereby 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

“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biotech clients need for clinical success,” commented Yvonne Lungershausen.

According to Frost & Sullivan as part of the independent analyst review of the company for the CRO Award:

“Avance Clinical remains a trusted partner, earning a reputation for delivering the overall best in the CRO industry. With its strong overall performance, Avance Clinical earns Frost & Sullivan’s 2022 Asia-Pacific Customer Value Leadership Award in the contract research organization industry.,”

Find out more:

  • Learn about the Australian Advantage here 
  • Learn about the GlobalReady model 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 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

Avance Clinical Wins Frost & Sullivan Customer Value Leadership Award 2022

By Other newsNo Comments

Adelaide, Australia/San Diego, USA – After an extensive review by CRO industry analysts comprising executive interviews and background sector research, Frost & Sullivan has recognized Avance Clinical, the leading Australian-based biotech CRO with US operations, with the Frost & Sullivan’s 2022 Asia-Pacific Customer Value Leadership Award.

“Avance Clinical remains a trusted partner, earning a reputation for delivering the overall best in the CRO industry. With its strong overall performance, Avance Clinical earns Frost & Sullivan’s 2022 Asia-Pacific Customer Value Leadership Award in the contract research organization industry,” said Frost & Sullivan as part of the independent analyst review of the company.

“With over two decades of experience, Avance Clinical assists biotechnology (biotech) sponsors in the early phases of their drug development. It delivers prompt, adaptive, client-oriented solutions and customizes its solutions based on its client’s needs rather than the “one-size-fits-all” approach, which is a key differentiator,” noted the report.

Frost & Sullivan identifies APAC as one of the fastest-growing CRO markets globally with an estimated value of nearly USD$8 billion in 2021.

Frost & Sullivan said the main market drivers in APAC included a significant cost advantage, supporting infrastructure, and wide-ranging patient diversity mirroring western nations’ disease prevalence. Frost & Sullivan forecasts a compound annual growth rate of 15.9% from 2021 to 2027.

The Frost & Sullivan analyst report on Avance Clinical also said:

“Avance Clinical’s approach goes beyond its extensive expertise and best-in-class capabilities, with customer value as a strategic imperative. Through the years, the company has earned an outstanding reputation supporting clients’ path toward seamless clinical trial execution.”

The report identified the following further benefits of working with Avance Clinical:

  • Price/Performance Value: Products or services provide the best value for the price compared to similar market offerings
  • Customer Purchase Experience: Quality of the purchase experience assures customers that they are buying the optimal solution for addressing their unique needs and constraints
  • Customer Ownership Experience: Customers proudly own the company’s product or service and have a positive experience throughout the life of the product or service
  • Customer Service Experience: Customer service is accessible, fast, stress-free, and high quality

Brand Equity: Customers perceive the brand positively and exhibit high brand loyalty Avance Clinical CEO Yvonne Lungershausen said this is the third consecutive year the company has been recognised by the analysts at Frost & Sullivan and the team should be proud of their work supporting our global biotech clients.

“This recognition is extremely important for our company because it reinforces the value of our agile clinical solutions that support accelerated clinical development for our international biotech clients.”

“Our US team should also be commended because this award is for the entire company,” said Yvonne Lungershausen.

The Australian and US capabilities feature in the analysts’ findings:

“Avance Clinical’s Australian operations offer clients the opportunity to maximise significant rebates of up to 43.5%, expedited approvals, and world-class trial data for their early-phase clinical development. Our GlobalReady service supports biotechs’ progress through later phases in North America for FDA approvals.”

Frost & Sullivan applies a rigorous analytical process to evaluate multiple nominees for each award category before determining the final award recipient. The process involves a detailed evaluation of best practices criteria across two dimensions for each nominated company. Avance Clinical excels in many of the criteria in the contract research organization space.

Find out more:

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

Avance Clinical Sponsors China BioPharma Award at the Global Scrip Awards, London

By Other newsNo Comments

Adelaide, Australia/San Diego, USAAvance Clinical, the leading Australian-based biotech CRO with US operations will sponsor and present the China BioPharma Award at the global biotech Scrip Awards in London next month.

Avance Clinical congratulates the China BioPharma Award shortlisted companies:

  • Anticancer Bioscience
  • BeiGene China
  • Brii Biosciences
  • Clover Biopharmaceuticals
  • Everest Medicines

Avance Clinical CEO Yvonne Lungershausen will present the award at the official ceremony on 30 November 2022. Avance Clinical’s Global Head of Business Development Liahna Toy will also attend the event which brings together more than 400 biotech companies.

Discussing the China BioPharma Award Yvonne Lungershausen said:

“With more than 20% of our biotech clients coming from China, we are sponsoring this award to shine a global spotlight on the calibre of innovation we see first-hand from the region.

Many of Avance Clinical’s biotech China clients are planning FDA approval in North America. Working with Avance Clinical, our clients execute on that strategy by starting their drug development program in Australia and pivoting to North America for greater site and patient access in later phase trials. These clients are already benefiting from Avance Clinical’s recent expansion into North America and the new GlobalReady service which enables them to work seamlessly with our data and project teams across all phases and regions.

Avance Clinical’s Australian operations offers clients the opportunity to maximise on significant rebates of up to 43.5%, expedited approvals, and world-class trial data for their early phase clinical development. Our GlobalReady service supports biotechs’ progress through later phases in North America for FDA approvals.

We have shown, with our high growth and industry-leading repeat business rates that our focus on gold-standard technology paired with solution-orientated clinical experts is the mix our biopharma clients need for clinical success.”

Now in its 18th year, the Scrip Awards brings together industry leaders to celebrate and recognise the very best innovations and achievements in global biopharma. Winners will be celebrated across 15 categories.

Avance Clinical is the leading Australian-based biotech CRO with US operations providing global regulatory standard clinical research services across all phases for the international biopharma industry.

The company has a global reputation for agile clinical solutions to support accelerated clinical development for international biotech clients.

Avance Clinical is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) for vaccines and GMO therapies clinical trials.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Find out more:

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 two 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.

Avance Clinical Wins International Health Award for Biotech CRO Services

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Australia – Avance Clinical, the leading Australian-based biotech CRO with US operations has won the South Australian Premier’s Export Awards – International Health category. The award recognises excellence in clinical services exports.

The Premier of South Australia Peter Malinauskas, and Minister for Trade and Investment Nick Champion, presented the Premier’s Export Awards to Avance Clinical CEO Yvonne Lungershausen at the awards industry event today.

This follows Avance Clinical’s selection as finalist for the Informa Pharma Intelligence Awards 2022 Best Contract Research Organization in APAC.

Avance Clinical, which is backed by global private equity firm The Riverside Company, recently acquired a leading CRO in North America to expand services and offer their biotech clients US sites for later phase studies.

CEO Yvonne Lungershausen said Avance Clinical is now the leading Australian-based biotech CRO with US operations.

“We are honoured to be selected for the award. We are a major employer with more than 220 staff and we bring significant biotech clinical research business into South Australia and Australia.

Clinical research is a high-value export that keeps our medical, research, and biopharma sectors at the forefront of international knowledge and innovation.

The majority of our clients are from North America, the EU, and Asia so we really are an internationally-focused organisation.

Avance Clinical has a global reputation for agile clinical solutions to support accelerated clinical development for our international biotech clients and we are very proud of our growth and success in recent years.”

The company provides global regulatory standard clinical research services across all phases to the international biopharma industry.

Avance Clinical is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) for vaccines and GMO therapies clinical trials.

“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector,” said Lungershausen.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Find out more:

About Avance Clinical

Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand 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 two 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.