Reports and Brochures

Explore Bellberry’s corporate publications, annual reports, and workshop summaries. These documents provide insights into our activities, research ethics leadership, and ongoing contribution to Australia’s research community.

NAMs HREC Review Checklist

Bellberry and ASCEPT, the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, are pleased to release the draft NAMs HREC Review Checklist for consultation.

Meeting 1 November 2024 Melbourne

The aim:

To understand what’s required to enable the responsible, ethical use of NAMs in the transition from preclinical research to clinical trials. Perspectives from

  • Regulator
  • HREC leaders
  • Technology developers
  • Sponsors
  • Researchers

Meeting 2 October 2025 Melbourne

Aims:

  • Explore regulatory expectations and acceptance of data from NAMs
  • Provide hands-on understanding of applications using NAMs to support FIH trials
  • Identify practical barriers and strategies to implement NAMs through case studies and group discussions
  • Empower participants to evaluate data from NAMs critically and navigate uncertainties

Meeting 3 July 2026 Melbourne

Launch of practical guidance for ethics review and decision-making using NAM guidance and Delphi methodology. Draft checklist open for consultation until 5 October 2026.

NAMs Workshop 2 Summary Report

Melbourne, 24 October 2025

Bellberry and ASCEPT (Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists) are pleased to release the summary report from the second NAMs workshop.

The workshop focused on the practical use of NAMs to support first-in-human clinical trials, including regulatory, ethical and practical considerations for applicants and HREC members.

The report captures perspectives from Australian consumers and speakers from the NIH and Eurpean Comission. The main focus of the workshop was a case study based on a recent Bellberry-approved study supported by NAM data. The report summarises the discussion and explores how the findings can inform practical guidance for presenting and assessing NAM data in first-in-human clinical trial applications.

Bellberry and ASCEPT are now working with the sector to develop guidance material, expected to be launched in July/August 2026.

Reconciliation Action Plan

Bellberry’s Reflect Reconciliation Action Plan (RAP) was officially endorsed by Reconciliation Australia on 1 May 2026 and is now publicly available on the Reconciliation Australia website.

Download the Bellberry Reconciliation Action Plan (RAP)

Impact Report 2025

We are proud to release the Bellberry Impact Report for 2025. To download your copy of the report please click the button below.

Corporate Brochure

Through nationally recognised processes, Bellberry supports research across clinical trials, health and medical research, medical device, digital health and AI, social science, evaluation and observational studies.

Find out more about our key services and who we work with in our Corporate Brochure

Clinical Trial Activity Report 2025

The Clinical Trial Activity Report (CTAR) presents a summary of Bellberry’s ethics review activity across all Human Research Ethics Committees (HRECs) in 2025.

It highlights trends in clinical trial submissions, study types, and participant demographics, demonstrating our commitment to transparency and continual improvement.

This report is designed to inform researchers, institutions, and regulators about the scale and nature of research overseen by Bellberry each year.

NAMs Workshop 1 Summary Report

Melbourne, 30 November 2024

Bellberry and ASCEPT (Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists) are pleased to release the summary report from the first NAMs workshop.

The introductory workshop brought together regulators, ethicists, researchers and industry leaders to consider how Australia can support the responsible use of NAMs, reduce reliance on animal models, improve translational outcomes and support the transition to first-in-human and early clinical trials.

The report summarises key themes from the workshop, including drivers for NAM adoption, validation, regulatory and ethical considerations, therapeutic scenarios explored by participants, and priorities for policy, funding and collaboration.