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Avance Clinical Wins Excellence in Business Award 2021

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The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical has won the Fast Movers SA Excellence in Business Award 2021 sponsored by international accounting and business advisory firm BDO.

According to BDO the Fast Movers SA Excellence in Business Award, recognises a company that has achieved exceptional and sustained growth year on year, and demonstrates innovative strategies and market leadership, as shown by leading CRO Avance Clinical.

“BDO is proud to be involved with an awards program that recognises South Australia’s fastest growing, most innovative and arguably smartest businesses. Avance Clinical CEO Yvonne Lungershausen and her team focus on providing quality services while maintaining a global perspective but also a local South Australian focus – particularly as an employer of choice, making them a worthy winner of this award,” says Rudy Pieck, Managing Partner, BDO South Australia.

Avance Clinical CEO Yvonne Lungershausen, said

“As the Australian CRO for biotechs we are very pleased to be recognised for our business excellence,” she said.

“The Fast Movers Excellence in Business Award is recognition of the quality work conducted by Avance Clinical, and how we manage our growth trajectory as we continue to attract biotechs from around the world for clinical research services.

It really is all about our staff and how we support and nurture them with a team environment, training, and career progression and, most importantly, the time and resources to deliver the very best for our clients.

Australia is highly regarded around the globe for quality clinical research, rapid start-up, and the world’s most attractive rebate of 43.5% on clinical trial spend.

Biotechs from the US, Asia and EU are discovering the enormous benefits of conducting their clinical research in Australia and, perhaps most importantly, that our clinical data is accepted by all the major international regulatory authorities.”


Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4 billion Market Demand

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The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023.

Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR).

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).

In Australia, dealings with GMOs in clinical research requires authorisation under the Gene Technology Act 2000. The OGTR administers the Gene Technology Act 2000, and has specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating dealings with GMOs.

The global market for genetic modification therapies is expected to grow from $2.3 billion in 2018 to reach $17.4 billion by 2023, growing at a compound annual growth rate of 49.9% (BCC Research, 2018). The utilization of gene modification technologies used in COVID-19 vaccine products is likely to translate in further growth in this field of therapeutics.

Avance Clinical CEO Yvonne Lungershausen, said OGTR accreditation is important for our international clients. “Our clients need to know that their CRO has all the necessary credentials and is capable of delivering the highest of clinical research standards in this exciting and rapidly evolving sector,” she said.

Avance Clinical currently has a number of GMO studies underway and is expanding its services further to accommodate increasing global demand.

Avance Clinical Invited to Present “Decentralized Trials – No Going Back” for Oracle Health Sciences Connect

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The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been invited to present on the future of decentralized clinical trials at the Oracle Health Sciences Connect conference.

Title: Decentralized Trials – No Going Back

Time: 23 April, 2021 – 3.05 pm (Australia/Adelaide ACST).

Avance Clinical CEO Yvonne Lungershausen, shared the company’s insights on the future of Decentralized Clinical Trials (DCTs) and the technology and patient factors that will determine success.

Avance Clinical uses the full range of eClincial technologies to support clients wanting DCTs or a site-based approach while still leveraging advance technology including ePro, eSource  and eConsent.

“DCTs are fast becoming the new norm and this is an incredible opportunity for the drug development sector as well as the diverse and remote patient populations that will now have access to clinical trials,” said Lungershausen.

“The pandemic has been the catalyst in speeding up the adoption of decentralised clinical trial methods, as people stopped participating in trials and visiting clinics. Trials have stalled putting lives and significant investments at risk.”

Yvonne Lungershausen said 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

And she said challenges include:

  • Missed human-to-human contact and continuity of patient care
    • Investigational product distribution to more remote destinations
    • Oversight of compliance and study procedures in the patient’s home

The presentation also covers advances in artificial intelligence (AI), machine learning, cloud computing and blood self-collection devices which are all revolutionising 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 and a finger prick whereas others do not, making clinical trials even more convenient.

Avance Clinical Featured in Endpoints News

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Is Australia the next Global Destination for Phase 2?

According to TrialTrove, there have been 1,411 industry sponsored clinical trials recruiting in Australia and New Zealand since 2019, with 330 currently planned. Of these there are 144 Phase 2 studies and 114 in Phase 3 and 4 studies.

A year ago Australia was largely known predominantly for its early phase capabilities. However much has changed with Australia becoming the “COVID-19 free” envy of the world. Australia regularly records zero new daily COVID-19 cases, backed by the world’s leading contact tracing systems, mandatory travel quarantine, and strict borders. Read full story here

COVID-19 and the APAC CRO Landscape | Avance Clinical featured in Biospectrum Asia

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“Australia has been recognized globally for its handling of the COVID-19 pandemic with strict quarantine systems and advanced contact tracing, resulting in low numbers of cases and deaths. Therefore we have seen a dramatic increase in the number of USA sponsors moving their trials to Australia.” Read the full article here

The global disruption presented a number of operational challenges including:

  • A need to rapidly pivot to full adoption of eClinical technologies because traditional working practices and methods were no longer practical.
  • Initially, patient/volunteer participation in clinical trials decreased at some sites because participants were not wanting to attend clinics or hospitals for fear of the virus.
  • Some sites in Australia were temporarily closed while they introduced new work practices to protect staff and patients/volunteers.
  • COVID-19 studies targeting countries with significant patient populations, rapidly dominated the global sector, resulting in decreased attention, site resources and funding for non-COVID related therapies.
  • Employee adaptions to new working environments i.e. working from a home office.
  • Conduct of business development activities needed to change as the ability to create new business connections and partnerships via conferences and face-to-face meetings became no longer possible.

News: Avance Clinical Adds Oracle Argus Safety and Pharmacovigilance Platform to its Clinical Technology Solutions

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The leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical has further enhanced its innovative clinical research technology solutions with the addition of Oracle Argus.

The implementation of Oracle Argus pharmacovigilance system is the latest addition to Avance Clinical’s state-of-the-art systems suite, supporting clinical trial management services.

Safety management and reporting is one of the most important aspects of early clinical development, an area of deep strength and expertise for Avance Clinical.

The addition of Oracle Argus complements the experience of Avance Clinical’s dedicated Safety & Pharmacovigilance team headed by Pilar Garzon who has over 12 years’ experience in clinical trial safety management.

“I am very excited to have Oracle Argus as our premier safety system at Avance. I have worked with this platform for several years and consider it to be the best tool in the field,” Pilar commented.

“Oracle Argus further enhances Avance Clinical’s safety management processes within a validated built-for-purpose framework providing automation and efficiency improvements to our existing workflow throughout at all stages of safety processing and reporting,” said Gabriel Kremmidiotis, Avance Clinical’s Chief Scientific Officer.

The Argus system is of particular importance for Phase II clinical trials involving patient populations where the observation of adverse events is more prevalent compared to Phase I healthy volunteer trials. Avance Clinical is increasingly in demand for Phase II studies so the Argus platform is an important addition the technology solutions offering.

“We are excited to welcome Avance Clinical to our global community of Argus customers,” said Bruce Palsulich, Vice President, Safety Product Strategy, Oracle Health Sciences. “Argus provides proven compliance with continuously changing worldwide regulations, and its built-in automations, integrations, and usability significantly reduce manual work and maximize efficiency.  We are pleased that Avance Clinical has chosen to standardize on Argus for safety case management.”

Argus Cloud, the industry’s best-in-class platform for safety and pharmacovigilance regulatory compliance, offers a scalable and secure solution within a multi-tenant ICH E2B R3 XML compliant database for our clients.

As clinical research becomes more complex and spans regions with diverse regulatory requirements, it is vital to have a technology solution like Argus that can accommodate full safety and regulatory compliance on a single platform.


By Company Awards, Company NewsNo Comments

Avance Clinical has positioned itself as a global leader in early phase clinical trials by developing innovative strategies and approaches to initial phase development. It helps global biotech companies set up clinic and achieve proof of concept faster with a data package that stands up to the scrutiny of global regulators. The company is well reputed for proven support of the biotech industry by providing scientific and regulatory expertise to help develop the best strategy to achieve clinical trial outcomes in the most time- efficient manner. Read the full report here.

ENDPOINTS NEWS: How Innovative Technologies and a Dedicated Site Network is Driving Patient Recruitment for Biotech Clinical Trials in Australia

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Australia’s CRO for biotechs, Avance Clinical, deep dives into the patient recruitment landscape identifying the mechanisms and processes that deliver exceptional patient recruitment for early phase trials in Australia.

Avance Clinical also offers models for later phase pivots to large patient populations in Central and Eastern Europe and the US via exclusive collaborations with more than 3,500 sites. Learn more here.

In Australia, Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 Weeks, plus there is up to a 43.5% refund on clinical trial spend.

Avance Clinical is the Australian-owned full-service biotech CRO that has been providing high-quality clinical research services across all phases to the US, APAC, and EU drug development industry for over 20 years.

“Our team has extensive therapeutic area knowledge and expertise and has conducted drug trials with large molecules, small molecules, gene therapies and devices providing high-quality clinical research services fit for global regulatory standards,” said Yvonne Lungershausen, Avance Clinical’s CEO
“We offer end-to-end in-house clinical research services including drug development consultation, medical writing, clinical project management, trial monitoring, pharmacovigilance, data management, statistical and pharmacokinetic services, CDISC and external and internal auditing.”

Read full article Here

Avance Clinical Client Atossa Therapeutics Completes Enrollment of Phase 1 Clinical Study of AT-301 Nasal Spray Being Developed for the Coronavirus Causing COVID

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The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical is pleased to share the news that their client Atossa Therapeutics (NASDAQ: ATOS) has announced completion of enrollment in its Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray for the treatment of COVID-19. AT-301 is being developed for at home use enabling management of the infection symptoms with at home quarantine and potentially preventing disease progression.

Avance Clinical Chief Scientific Officer Gabriel Kremmidiotis PhD, BSC Hon said:

“With a number of countries around the globe currently experiencing secondary waves of COVID-19 infection spread, the need for vaccines and therapies is significant and the ability to deliver fast start-up and execution of clinical trials to expedite development of such products, like AT-301, is essential. Avance was able to deliver start-up and execution of the AT-301 trial in record time. We have a very experienced team who worked effectively with Australian Human Research Ethics and a dedicated Phase I unit based here in South Australia in delivering this great result for Atossa.”

According to Atossa Therapeutics:

Atossa Therapeutics, Inc., a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, announced it has now completed enrollment in its Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray.

“Completing enrollment is a significant milestone and comes at a time when we are seeing a new wave if infections in certain geographies and an increased focus on developing therapies to treat COVID-19,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “While the virus presents significant danger overall, the vast majority of people testing positive for COVID-19 do not require hospitalization and instead quarantine at home while they manage their symptoms and attempt not to infect those around them. As there are no currently FDA-approved treatments to help these patients, we are developing AT-301 for at home use so that they can recover faster.”

Atossa plans to identify potential partners who are developing COVID-19 diagnostic tests so that AT-301 nasal spray may be co-developed and commercialized with the goal of making the AT-301 therapy available at the time a person tests positive for the coronavirus. Atossa also plans to develop its nasal spray to potentially help prevent COVID-19 infection — particularly for people in high risk environments — including, for example, people living with a patient infected with COVID-19, healthcare workers, emergency responders and teachers. In addition to seeking a partner, Atossa’s next steps with this program include contracting for a commercial supply of the nasal spray devices; reporting preliminary top line results from the Phase 1 study; and completing regulatory filings and any necessary approvals to launch a Phase 2 study, which it is planning for the first half of 2021.

The ongoing Phase 1 study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups. Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A at two different doses. Part B is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives are to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation. The study is being conducted in Australia.


Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19. For more information, please visit

See full announcement here.

Avance Clinical Wins MasterControl 2020 Innovation Excellence Award

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The leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical today accepted the MasterControl 2020 Innovation Excellence Award in a virtual ceremony.

Avance Clinical made the announcement today at AusBiotech 2020 (28 – 30 October, 2020).

Avance Clinical CEO Yvonne Lungershausen said the company was very pleased to be awarded such recognition by MasterControl, a leader in the clinical digital management technology.


“The award acknowledges our leadership as Australia’s biotech CRO and it provides further confidence to our clients that we are serious about delivering quality clinical research services by being nimble and adaptive, and by utilising state-of-the-art systems that are compliant with industry standards, such as MasterControl eQMS,” said Yvonne Lungershausen.

“Avance Clinical invests significantly in the industry’s leading clinical technologies making it one of the most advanced CROs globally for digital clinical research management and eClinical solutions.”

On presenting the Innovation Excellence Award, MasterControl said the award recognises “the power of innovation and celebrates companies who feel the same way we do, who are not afraid to shed the status quo to find their own path and who push boundaries and spearhead important changes within their industries. Companies driven by innovation who truly live and breathe it.”

Avance Clinical Director Quality Assurance, Priyanka Chamoli, said:

“Receiving the award from MasterControl is a testament of our commitment to invest in our Quality Management System and to continually improve and strengthen it. This Award recognises and provides visibility to our efforts to push boundaries and adopt this significant change not just for the Quality Assurance department but across-the-board in the organisation.”

“MasterControl eQMS enables accurate, streamlined processes for Document Control and Training. Avance Clinical, which is on a significant growth trajectory, requires robust procedures as part of our QMS. MasterControl has allowed our staff to create/review and access our controlled documents in real-time and the automated link between different modules enables timely delivery of training.”

Avance Clinical Director Compliance and Training, Lisa Eglinton said:

“MasterControl Training Module provides a robust, user-friendly method for the delivery of role-specific training programs to all staff.  The system provides a real-time indication of training status to Trainees and their Line Managers which ensures training compliance across the company.”

Avance Clinical is the leading Australian owned CRO 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.

Considering Australia? Contact us about your next study.

(From left to right) Priyanka Chamoli, Director Quality Assurance, Emma Woolman, Senior Compliance and Training Officer,  Yvonne Lungershausen, Avance Clinical’s CEO, and Lisa Eglinton, Director Compliance and Training.