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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 favorable 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://avancecro.121group.dev/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 recognized 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 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 Mold 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 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’s USA Biotech Survey Finds 21% Not Aware Australian Clinical Data is Accepted by the FDA and Other Major Regulatory Authorities

By Company News, Conference NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical announced the results of their Australian Clinical Trials Knowledge Survey with Endpoints News as part of their presence at BIO Digital 2021.

Results from the survey found:

  • 21% were not aware Australian data is accepted by the FDA and other major regulatory authorities
  • less than half of respondents were aware of Australia’s 43.5% rebate on clinical research spend
  • only 52% knew that studies could achieve regulatory approval in under 5 weeks in Australia

The survey was sent to Endpoints News subscribers in biotech hubs on the USA east and west coasts.

The Avance Clinical team is attending BIO Digital 2021 virtually and is available on the BIO One-on-One Partnering™ platform to discuss the benefits of conducting trials in Australia.

Avance Clinical CEO Yvonne Lungershausen, said the survey was designed to determine awareness levels among biotech companies around the key benefits of conducting clinical trials in Australia.

“Sponsors are well aware of the quality of research from Australia however it seems from the survey that some key benefits including data acceptance, the rebate, and accelerated regulatory approval are still not widely known,” said Yvonne Lungershausen.

“The clinical trial environment in Australia supports rapid regulatory approval and includes one of the most attractive rebates on clinical costs as part of the Australian Government’s clinical trial attraction incentive program.”

Avance Clinical has recently won the BDO Excellence in Business Award 2021 for rapid managed growth and attracting and nurturing experienced staff in a competitive global environment. The mid-sized CRO has a reputation for going beyond the industry standard time and support for Sponsors and providing staff the training and resources needed to deliver excellence in clinical research management.

Avance Clinical Releases Industry Survey Results at BIO Korea 2021 – Data Quality the Top Criteria for Selecting a CRO

By Company News, Conference NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical shared results of a recent industry survey conducted by the company that found data quality to be the most important criteria for selecting a CRO for Phase ll studies in Australia.

Results from the survey found 63.64% of respondents selected data quality as the Key operational consideration when planning Phase II, followed by access to patients, then CRO therapeutic area expertise, cost, and access to KOLs.

Avance Clinical is attending BIO Korea 2021 virtually and is available via the Partnering platform to discuss the benefits of conducting trials in Australia. Avance Clinical has extensive experience in conducting trials in oncology, CNS, cardiovascular, infectious diseases and dermatology.

Avance Clinical CEO, Yvonne Lungershausen, said South Korea is recognized globally for its thriving biotech sector and the CRO is keen to connect with companies wanting regional alternatives for their clinical development.

“As Australia’s CRO for biotechs, we are seeing an increasing number of South Korean biotechs selecting Australia to accelerate their Phase I and II trials,” she said.

“The high-quality of our data for FDA and other regulatory authority approvals is a key factor in the decision-making process.”

The clinical trial environment in Australia supports rapid startup and a rebate of more than 40% on clinical costs as part of the Australian Government’s clinical trial attraction incentive program.

In addition, Avance Clinical is accredited by the Office of the Gene Technology Regulator (OGTR) so it can manage gene technology trials in Australia.

This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).

Avance Clinical Announces Expanded eClinical Solutions for Biotech Clinical Trials at BioPharm America

By Company News, Conference News, Partner NewsNo Comments

The leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical has expanded its eClinical solutions offering, with advanced digital clinical tools for enhanced patient engagement, visibility, data capture, and analysis. www.avancecro.com/eclinical-solutions

Avance Clinical made the announcement at BioPharm America (September 21-24, 2020)

Avance Clinical’s biotech clients now have the option to deploy the latest eClinical solutions to maximize the value of study data and deliver real-time visibility on study progress.

Avance Clinical CEO Yvonne Lungershausen said:

“Our Data Management team works with eClinical leaders such as Medrio to offer regulatory compliant and patient-centric tools for rapid start-up and continual data flow.

These tools improve patient engagement and data collection and allow Sponsors to stay informed at every step with Sponsor visible portals.”

The Avance Clinical eClinical services include the following:

eSource

  • Direct data capture of source data on site
  • Forms customized by Avance Clinical Data Management team
  • Edit checks built into forms; instant firing of queries once data is entered
  • Option for data to be collected off-line and synced when on-line is available
  • Fully integrated with Medrio EDC, data visible for Sponsor review instantly
  • Remote monitoring and data review on ongoing basis
  • Avance Clinical provision of tablets if required


eConsent

  • Electronic consent including patient sign-off and investigator confirmation
  • Customizable to include animations, videos and questions as required
  • Forms customized by Avance Clinical Data Management team
  • Link via email to patient
  • Compatible with any device and internet system (smart phones, tablet, laptop, desktop)
  • Integrated with Medrio EDC
  • Link can be shared with HREC as part of submission package


ePRO

  • Electronic capture of patient-reported outcome, including diary data, dosing compliance, questionnaires, VAS/Pain scales
  • Forms customized by Avance Clinical Data Management team
  • Link via email to patient
  • Options for emails and reminders at set times during the day or week
  • Timezone adjusted to patient’s location
  • Compatible with any device and internet system (smart phones, tablet, laptop, desktop)
  • Fully integrated with Medrio EDC, data visible for Sponsor review instantly

Glynn Morrish, Avance Clinical Director Biometrics said:

“Direct electronic capture of study information and the complimentary suite of solutions offered by Avance Clinical allows the company and its clients to maximize clinical trial efficiency and flexibility while ensuring data integrity is preserved.

Our highly trained and experienced biometrics team are excited to continue to work at the forefront of innovation and technology and provide services that offer stability and robustness to studies being conducted in an ever-changing global environment.”

Avance Clinical is an Australian-owned Contract Research Organization that has been providing high-quality clinical research services fit for global regulatory standards to the local and international drug development industry for 20 years.