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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.

AUSTRALIA & ASIA-PACIFIC CRO MARKET REPORT: Frost & Sullivan

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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.

ABOUT ATOSSA THERAPEUTICS

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 www.atossatherapeutics.com.

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.

Biotechs get scalable early to late phase clinical offering from Cromos Pharma and Avance Clinical collaboration in Australia and Europe

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Dublin/Ireland – Adelaide/Australia – Two dominant regional contract research organizations (CRO), Avance Clinical and Cromos Pharma, with operations in Australia and Central/Eastern Europe, respectively, are successfully collaborating on a scalable clinical solution for biotechs.

The collaboration allows biotechs to quickly start their pre-IND early phase studies in Australia, then expand to Central/Eastern Europe to access the large patient populations for their Phase 2 and 3 studies.

Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5% on clinical trial costs, throughout all study phases, across both regions.

“We are very excited about this model that seamlessly incorporates two of the most compelling and complementary international clinical research hubs for our biotech clients from early to late phase studies,” said Yvonne Lungershausen, CEO of Avance Clinical. “Our eClinical and early phase expertise is well augmented by Cromos Pharma’s track record in late stage trials and rapid enrollment capabilities,” she continued.

“We have been collaborating with Avance Clinical and referring clients to each other for years,” remarked Vlad Bogin, CEO of Cromos Pharma. “But it was a true Eureka moment when we realized that combining Australia’s 43.5% tax rebate with Central/Eastern Europe’s unbeatable recruitment rates is a paradigm shift in how clinical trials should be conducted,” he concluded.

Cromos Pharma can access hundreds of millions of patients via more than 2,500 sites in Central/Eastern Europe.

Ends

About Cromos Pharma www.cromospharma.com

Cromos Pharma provides tailored and effective clinical trial solutions to support the development of drugs that transform healthcare. An international CRO with over 15 years’ experience, we offer fully integrated services performing all aspects of clinical trials in all clinical phases and in a wide range of therapeutic areas. Cromos Pharma delivers rapid recruitment and excellent patient retention as well as expert study design and management. Cromos Pharma has strong regional experience in Central and Eastern Europe with global coverage provided by its US bases in Portland, Oregon and Miami, Florida. Cromos Pharma’s European HQ is in Dublin, Ireland. At Cromos Pharma, we know how important your product is. When the stakes are this high, you need a high-performance partner.

Key benefits:

  • International expertise combined with in-depth regional knowledge in Central and Eastern Europe (300+ clinical trials conducted in 70+ indications).
  • Extensive PI/site and patient network (40,000+ patients enrolled from nearly 2,500 trial sites).
  • Unparalleled patient recruitment – our team met or shortened project timelines in 95% of conducted trials.
  • Responsible recruitment is supported by Cromos Pharma’s “No Patients-No Payments” initiative – a unique risk-sharing program.
  • Extremely short startup timelines (e.g. Georgia where we assure a study launch in less than 2 months).
  • Expertise in innovative, generics and biosimilar global studies (NDAs, ANDAs, BLAs, 505b2).
  • Regulatory inspections and audits that attest to the highest quality of data: EMA in 2019 (1-week oncology site inspection); FDA in 2017 (2-week oncology site inspection).
  • Clinical Development Strategy – we provide expert guidance on study design, favorable venues, local and global landscape to improve study outcomes.

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

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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 maximise 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 customised 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
  • Customisable to include animations, videos and questions as required
  • Forms customised 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 customised 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 maximise 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 Organisation 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.