Category: <span>Blog</span>

We’re proud to share Bellberry’s 2025 Impact Report – our first report bringing together key insights, data and achievements from the past year.

Our stories from 2025 highlight how we continue to support ethical research and promote best practice across the sector, while giving back to the medical research community.

This report reflects the collective efforts of the Bellberry community and our ongoing commitment to protecting research participants and strengthening research quality.

Download the full report below to learn more about our impact

The Bellberry office will be closed for the Easter break on Friday 3 April and Monday 6 April.

Reopening at 9am on Tuesday 7 April.

Have a safe Easter break.

The Bellberry Team

When a potential new medicine is tested on humans for the first time it is a milestone. It is thoroughly tested for safety before reaching this stage.

Often, it’s tested on animals, but increasingly New Approach Methodologies (NAMs) are being used (previously known as Non-Animal Models). NAMs are non-animal or reduced-animal scientific methods used to evaluate the safety and efficacy of drugs. These alternative technologies can include in-vitro human models (such as organoids and organ-on-a-chip) and in-silico (computer-based) modelling.

Australia’s largest provider of Human Research Ethics Committee services, Bellberry, and ASCEPT (Australasian Society of Clinical and Experimental Pharmacologists & Toxicologists) have been working together to develop robust guidance for the use of NAMs.

Two workshops have been held with international and Australian experts over the last two years.

Following the last workshop, Alison Rogers spoke with three leaders in the field to find out more about this growing alternative technology to kick off the 2026 season of From Lab to Life.

Welcome to our newsletter for summer 2025.

The Bell contains a roundup of the activities Bellberry has been involved with in the last few months, including awarding our Bellberry-Viertel Senior Medical Researcher, CT:IQ activities, Thought Leadership series update, our office relocation and more.

If you have any feedback on our newsletter or any suggestions on what to include in our next edition please email bellberry@bellberry.com.au

Bellberry Newsletter Summer 2025

Our end of year meeting and submission dates are as follows:

The Bellberry office will be closed from COB Wed 24 December until 9am Mon 5 January.

We’re seeking a Project Officer with strong auditing and governance experience to help deliver services that support compliance with ICH-GCP, NHMRC guidelines, and regulatory frameworks. You’ll lead auditing activities, develop quality resources, build relationships with research sites, and drive continuous improvement across our services.

If you’re passionate about strengthening ethical, high-quality research, we’d love to hear from you.

• Project Officer Position Description
• Find out more and apply via SEEK

Last month at the Australian Academy of Health and Medical Sciences Gala Dinner in Canberra our new Bellberry-Viertel Fellow was announced!

Congratulations to Associate Professor ZongYuan 宗元 Ge 戈 of Monash University who is a medical AI specialist.

ZongYuan 宗元 Ge 戈 will use the five-year Fellowship to develop Australia’s first AI Unified Phenotype Foundation model for diagnosis, prognosis and discovery in healthcare.

Congratulations to the other two Viertel Fellows Dr Joanna Achinger-Kawecka and Dr Dustin Flanagan.

The Sylvia and Charles Viertel Charitable Foundation has awarded 70 Fellowships over 30 years and as a not-for-profit provider of Human Research Ethics Committee services, Bellberry is proud to be working with the Foundation and Equity Trustees to provide the third Fellowship.

Our end of year meeting and submission dates are as follows:

The Bellberry office will be closed from COB Wed 24 December until 9am Mon 5 January.

The National Statement on Ethical Conduct in Human Research is the principal reference for research involving humans in Australia and is the guiding document for Human Research Ethics Committees. The National Statement is released by the National Health and Medical Research Council (NHMRC) and is periodically updated to stay relevant to evolving research practices, ethical understanding and community needs.

The 2025 revision, originally due to take effect on 1 October 2025, has been postponed until early 2026. However, institutions are encouraged to adopt it earlier and Bellberry will apply the changes from 1 October 2025.

The 2025 revision of the National Statement incorporates a fully revised Section 4 and consequential or minor changes to almost all other sections. The revised National Statement includes the following major thematic changes in Section 4:

• framing the need for additional consideration for individual participants or groups of participants in terms of increased risk of harm, rather than in terms of vulnerability
• emphasis on inclusion of individuals and groups frequently excluded or under-represented in research
• drawing a distinction between research with people who are at increased risk due to characteristics or circumstances, and increased risk due to research contexts
• removal of the need for research involving participants potentially at increased risk to automatically require review by a full HREC, enabling the use of alternative review processes for lower risk research with the same participants, where appropriate.

The revisions also include recognition of issues related to research with Aboriginal and Torres Strait Islander people and communities in the Preamble and Section 1 of the National Statement and a revised Chapter 4.7.

We encourage all researchers to become familiar with the updates. A summary of the changes can be found on the NHMRC website.

In the September issue of our Operations Update please find articles on:

• New Bellberry office address
• New eProtocol registrations contact email
• Bellberry user satisfaction survey
• End of year meeting and submission dates
• Digital scribes
• National Statement 2025 Update
• When the study is full – what about the next screened participant?

As Australia’s largest provider of Human Research Ethics Committee services, Bellberry places great value on understanding the experience our users have of our services.  Every two years we invite our users to share their feedback through our User Satisfaction Survey. It’s part of our goal to continuously improve what we do.

Your feedback helps us celebrate what we’re doing well and highlight where we can improve.

The survey plays a vital role in strengthening our commitment to Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)’s quality improvement standards and ensuring we continue to deliver the highest quality of service in research ethics review.

If you are an investigator, researcher or staff member in a CRO or sponsor that uses Bellberry, we’d love to hear for you.

The survey closes on Friday 3 October 2025.

Today, September 25, we celebrate International Research Administrators Day!

This globally recognised day honours the contribution of Research Administrators in supporting and advancing research.

Bellberry marked the occasion with a morning tea, a chance to come together and applaud the role our Operations team plays in our organisation’s contribution and impact. Their expertise and dedication underpin every application we review, ensuring researchers receive the highest level of support across an extraordinary breadth of projects.

Over the past 21 years, Bellberry has supported more than 2,000 researchers, reviewing over 11,000 projects across 7,000 research sites nationwide. This is a remarkable legacy that demonstrates both the scale and depth of our impact on the Australian research sector.

So let’s celebrate today because it is your individual contributions that make this research, and this impact, possible!

We are pleased to release the summary report from the Bellberry & ASCEPT New Approach Methodologies (NAMs) Introductory Workshop, held in Melbourne, 30 Nov 2024.

The report captures insights from regulators, ethicists, researchers, and industry leaders on how Australia can support the responsible use of NAMs to reduce reliance on animal models, improve translational outcomes, and support the transition into first-in-human and early clinical trials.

It outlines:

• Drivers for NAMs adoption
• Validation, regulatory, and ethical considerations
• Therapeutic scenarios explored to test the role of NAMs
• Key priorities for policy, funding, and collaboration

To download the full report please visit our website here

The 2025 ACTA Trial of the Year Award was awarded to the PLUSS trial, recognising a groundbreaking study that could transform care for extremely preterm infants.

Led by Professor Brett Manley and conducted under the IMPACT Network, the trial investigated whether giving intra-tracheal budesonide with surfactant could reduce the risk of bronchopulmonary dysplasia (BPD)—a serious lung condition in premature babies. Conducted across 21 hospitals in Australia, New Zealand, Singapore, and Canada, the study enrolled over 1,000 infants and showed promising results.

Read more about the awards on the ACTA website.

Report highlights international confidence in Australian clinical trials

Global investment in Australian clinical trials is strong, with two thirds of Australian clinical trials, reviewed by Bellberry, funded by international companies according to its 2024 Clinical Trials Activity Report (CTAR).

Bellberry is Australia’s largest ethics and scientific reviewer of research involving humans reviewing approximately 40% of CTN (Clinical Trial Notification) trials in Australia.

Every year since 2019, Bellberry has released its Clinical Trial Activity Report (CTAR) to coincide with International Clinical Trials Day on 20 May. The CTAR describes the portfolio of research conducted in the prior year with Bellberry oversight.

Bellberry’s CEO, Kylie Sproston, says the 2024 data shows that Australia is uniquely placed to attract worldwide investment in clinical trials activity due to the high quality of its healthcare institutions and researchers.

“The 2024 Clinical Trial Activity Report shows that early phase trial activity remains a key strength with significant and continued growth over the last six years,” said Ms Sproston.

“The USA is the largest driver of early phase trials conducted in Australia, with Australia coming second and China third. Other top 10 countries include Germany, South Korea, Switzerland, the UK, Canada, France and Japan,” she said.

“Almost 50 per cent of the trials that Bellberry reviews are First in Human or Phase 1 trials, highlighting Australia’s strong reputation for this skilled and complex type of research.”

In 2024, oncology accounted for more than a quarter of the studies reviewed by Bellberry, while non-clinical trials made up more than 15 per cent of Bellberry reviews.

“Interestingly, we have seen a doubling of the number of social science research activities that Bellberry has reviewed in the last six years from 5% to 10% of total reviews,” said Ms Sproston.

“Australia’s capacity to support the full clinical development pathway is highlighted by the representation of trials in the 2024 CTAR from FIH through to Phase 4, devices, observational, qualitative, social science, registry, audit, and evaluation.”

View our 2024 Clinical Trial Activity Report here

Bellberry is a national, not-for-profit organisation that provides streamlined scientific and ethical reviews of human research established in 2004. It is the 2025 winner of the Championing Health Award in the Telstra Best of Business Awards.

For media queries please contact alisonrogers@bellberry.com.au or on 0488 995 868.