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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

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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 recognised 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 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.