Category: <span>Blog</span>

Meeting Date Submission Date
Weds 11 December Weds 27 November
Weds 18 December Weds 4 December
Bellberry office closure: COB Tuesday 24 December to Thursday 2 January 2025
Thurs 2 January Weds 11 December
Weds 8 January Weds 18 December
Weds 15 January Tues 31 December
Weds 22 January Weds 8 January

HREC meetings are held every Wednesday for the duration of 2024

The Bellberry Operations Update features practical information in relation to submissions and reviews, along with insights and updates from all sections of the Bellberry operations team and their respective teams.

If you have any feedback or suggestions on what you would like included in these updates please email bellberry@bellberry.com.au

Operations Update – Edition 16

Bellberry consists of a team of highly professional, innovative and dedicated people who are committed to making a difference within the research community.

Our culture is built on shared values:

That combination helps our professionals make a difference each day both individually and collectively.

Due to our continued growth we have a number of current vacancies:

Please visit the SEEK website for further information about any of these roles.

We’re delighted to be a state finalist in the Championing Health category of the Telstra Best of Business Awards! We’ve been designated this category for the impact that Bellberry is making in improving the health of Australians.

We are absolutely thrilled that our incredible team of staff and HREC members are getting this recognition for the extraordinary work they do protecting the welfare of the participant and improving the quality, efficiency and effectiveness of research, every day. Well done team!

Telstra Best of Business Awards Finalists (Championing Health)

Meeting Date Submission Date
Weds 11 December Weds 27 November
Weds 18 December Weds 4 December
Bellberry office closure: COB Tuesday 24 December to Thursday 2 January 2025
Thurs 2 January Weds 11 December
Weds 8 January Weds 18 December
Weds 15 January Tues 31 December
Weds 22 January Weds 8 January

HREC meetings are held every Wednesday for the duration of 2024

Without the patient or participant we would not have clinical trials. These are the people who, in some cases, are volunteering to have treatments that have never been tried on humans before.

In It’s All About the Participant we hear first-hand about what it’s like to be the participant and ask how could the experience be improved for others?

In Episode 9 of From Lab to Life we take a deep dive into the experience of those that have been on life-changing clinical trials.

We have made updates to several documents under Bellberry Applications (BA) and Monitoring of Approved Research (MAR). These changes aim to improve clarity, ensure compliance with current regulations, and enhance the efficiency of our processes. Please review the modified documents to stay informed about the latest updates: BA F5.1.1 Public Photographic & videographic release content We have reviewed and updated the document to clarify that consent is required whenever images are identifiable, not just when they are being published. We’ve expanded the consent statements and rewritten that section for clarity. [select-faq faq_id=’16035′]   BA G9 Advertising and social media We have updated the document to improve wording and provide further clarity, without changing our position. Since this update focuses on wording and clarity, we encourage users to read the document in its entirety instead of relying on small excerpts. Advertising: We now include detailed explanations of the difference between generic and study-specific advertising and guidelines on which types require HREC review. We’ve also added practical examples to help sites make these determinations. Media Coverage: We have added a new section to guide sites on when HREC review is necessary for media coverage and what should be included in a submission. Overall Improvements: We have revised the document to eliminate redundant information and reorganised it for greater clarity.   BA G12 Version control and document naming conventions Previously, BA G12 did not address the practice of distinguishing between Clean and Track change documents. The update to the guidance has introduced a standard notation system—using CL for Clean documents and TK/TC for Track Change documents—which could provide significant benefits:
  1. Clarity: Immediately identifies the type of document, reducing confusion.
  2. Version Control: Helps in tracking revisions and updates accurately.
  3. Efficiency: Facilitates quicker reviews and approvals by clearly showing changes.
While we recognise that version control practices are site-specific and not mandatory, incorporating this notation into our guidance could be particularly valuable for new research sites. It encourages best practices in documentation and version control. [select-faq faq_id=’16037′]   MAR G4 Progress and Final reports Administrative close out of expired applications The following wording has been added to MAR G4: Bellberry will administratively close applications for studies where ethical approval has expired for more than 45 days. If you do not submit a progress report or final report within 45 days of expiration, Bellberry will process a final report to close out the application administratively. The following wording will be on the final report letter: Bellberry has closed this application for administrative purposes following its expiration. If this study is ongoing at your site, you will need to submit a new application. Please contact Bellberry for assistance. Please note:

Bellberry consists of a team of highly professional, innovative and dedicated people who are committed to making a difference within the research community.

We’re delighted to currently have the following opportunities available to join our team:

Executive Assistant

An exciting opportunity for an experienced Executive Assistant to support our Executive team has arisen. This role is perfect for someone who thrives in a dynamic environment and is eager to contribute to a progressive organisation.

Please click here for the Position Description and visit the SEEK website for further information and to apply.

Human Research Ethics Commitee (HREC) Officer

The HREC Officer will provide a high level of support to the Bellberry Human Research Ethics Committee and be responsible for the administration of human research applications utilising the online submission system.

Please click here for the Position Description and visit the SEEK website for further information and to apply.

 
Meeting Date Submission Date
Weds 11 December Weds 27 November
Weds 18 December Weds 4 December
Bellberry office closure: COB Tuesday 24 December to Thursday 2 January 2025
Thurs 2 January Weds 11 December
Weds 8 January Weds 18 December
Weds 15 January Tues 31 December
Weds 22 January Weds 8 January
HREC meetings are held every Wednesday for the duration of 2024 Bellberry consists of a team of highly professional, innovative and dedicated people who are committed to making a difference within the research community. Our culture is built on shared values: That combination helps our professionals make a difference each day both individually and collectively. We currently have a vacancy for a Senior Administration Assistant providing high quality day to day administrative support to the Office of the Chief Executive. Ideal candidates are highly organized, adaptable, and experienced in a corporate setting, ready to grow with our dynamic company offering excellent benefits. Please click here for the full Position Description and apply here.

Have a question? Get in touch. Contact Athena Seltsikas, HR Business Partner on 08 8361 3222.

In ‘The Quiet Achiever’ we met someone who has made an extraordinary contribution to Australian health in a career spanning over six decades. Professor Emeritus Lloyd Sansom AO started his career as a pharmacist, going on to become Professor of Pharmacy as well as Head of the School of Pharmacy and Medical Sciences at the University of South Australia.

In 2002 he was awarded an AO and in 2004 his contribution to the University was recognised with the naming of the Sansom Institute for Health Research. He was also Chair of the Australian Pharmaceutical Advisory Council from 1991-2000 and Chair for the Pharmaceutical Benefits Advisory Committee from 2001-2012. Recently Lloyd retired as a member of Bellberry’s Board and in this episode he gives us insight into his life, work and lessons learnt.

The Founding Chair of Bellberry’s Board of Directors, Fraser Bell, has paid tribute to retiring Board member Professor Emeritus Lloyd Sansom AO for his 12 years on the Board.

“Once in a while a Board gets to work with a person of enormous integrity, wisdom, humility, humour and a capacity to roll up his sleeves and get things done,” said Mr Bell.

“Bellberry has had just that opportunity with Lloyd Sansom. Our company made huge strides forward due to Lloyd’s vision with our Thought Leadership Program in particular.

“While that is the obvious legacy, each of his fellow Board members and the executive team are better off for having shared the journey with Lloyd,” said Mr Bell.

Professor Sansom was Professor of Pharmacy as well as Head of the School of Pharmacy and Medical Sciences at the University of South Australia. In 2004 his contribution to the University was recognised with the naming of the Sansom Institute for Health Research.

He was also the Chair of the Australian Pharmaceutical Advisory Council from 1991-2000 and Chair of the Pharmaceutical Benefits Advisory Committee from 2001 to 2012.

Professor Sansom said it’s been a privilege to watch Bellberry grow over the last 12 years.

“Bellberry is a company that provides a high-quality service, but it does more than that. It is contributing to the advancement of the discipline of clinical trial research in this country and beyond,” said Professor Sansom.

Professor Andrew Wilson AO, who has recently retired as chair of the Pharmaceutical Benefits Advisory Committee will be joining the Bellberry Board.

Board Chair Fraser Bell has welcomed Professor Wilson’ appointment, “Andrew’s expertise and insights are well known to us and we are looking forward to working with him”.

Bellberry is Australia’s largest reviewer of human research reviewing more than 40% of CTN Clinical Trials in Australia. It’s a national, independent, not-for-profit organsiation focused on improving the welfare of human research participants and the quality, efficiency and effectiveness of medical research through its HREC reviews and philanthropic activities.

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

Professor Emeritus Lloyd Sansom AO

The ACTA Trial of the Year Awards were established in 2016 to highlight the outstanding Australian achievements that advance clinical practice and save or improve the lives of patients every year. This years awards were celebrated at the 2024 ACTA Trial of the Year Awards ceremony, held on International Clinical Trials Day, Monday 20 May 2024.

Among an outstanding national selection of collaborative, multicenter, investigator-driven trials, the winner of the ACTA Trial of the Year Award was:

ASAP (Australian Surgical Antibiotic Prophylaxis) Trial: Trial of Vancomycin and Cefazolin as Surgical Prophylaxis in Arthroplasty, Chief Investigator Prof Trisha Peel.

For further details on all the award winners please visit the ACTA website here.

Many congratulations to all the award winners.

International investment strong in Australian early phase trials

Overseas companies invest in two-thirds of all Australian clinical trials reviewed by Australia’s largest reviewer of human research, Bellberry, according to its Clinical Trial Activity Report (CTAR).

Bellberry reviews more than 40% of CTN (Clinical Trial Notification) trials in Australia and each year releases its CTAR on International Clinical Trials Day (20 May).

The data for the 2023 calendar year found that early phase clinical trials (first in human or Phase 1) involved investment from overseas companies (sponsors) with the top countries being the US, China, South Korea, the UK and Switzerland.

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

“Continuing previous trends, Australia is a lead destination globally for First in Human and Phase 1 trials, with strong interest from overseas sponsors in the Australian clinical trial ecosystem,” said Ms Sproston.

“Less well recognised is the depth in Phase 2 and Phase 3 clinical trials, totalling 28% of the portfolio.  Collectively, Australia can be a key partner for end-to-end delivery of clinical development of new health innovations.

“Other countries investing strongly in Australian clinical trials are France, Sweden, Taiwan, Germany and Canada. The data shows that we are a highly desirable destination for this skilled and complex work.”

Of the clinical trials reviewed by Bellberry in 2023, private sites conducted 89% of the research with 11% by public sites.

“This reflects the breadth and vibrancy of the privately based research sector including phase one units, hospitals, medical centres and research institutes,” said Ms Sproston.

More than a quarter of the clinical trials undertaken in 2023 were in oncology (27%) with other key areas of research including infectious diseases, neurology, dermatology, haematology, devices and social science (each within 5-10% of the total).

Download the 2023 Clinical Trial Activity Report

Bellberry is a national, not-for-profit organisation that provides streamlined scientific and ethical reviews of human research projects across Australia.  Its focus is on improving the welfare of human research participants and the quality, efficiency and effectiveness of medical research through its HREC reviews and philanthropic activities.

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

Opportunities are currently available to join our ever growing HREC review panels. Please refer to the article below for further information and contact Cathy Stevens if you are interested.