Category: <span>Blog</span>

At a time when the spotlight is firmly on clinical trials across the globe, ACTA is proud to host these annual awards that honour the remarkable Australians who advance our health system by designing, conducting, or participating in ground-breaking clinical trials and promote the importance of clinical trials and the expertise and complexity of the work involved.

The awards include the following 4 categories:

1. ACTA Trial of the Year Award
2. ACTA STInG Excellence in Trial Statistics Award
3. ACTA Consumer Involvement Award
4. ACTA Industry Partnership Award

The ACTA Industry Partnership award is new to 2022 and will be awarded to a collaboration between a commercial entity and a team of academic investigators that have combined to conduct a high-impact clinical trial.

To register for this event please visit the ACTA website here

Bellberry is once again proud to support this event as a premium partner.

The Trustees of the Sylvia and Charles Viertel Charitable Foundation have announced two classes of research grants to be awarded in 2022 and commencing in 2023.

Senior Medical Research Fellowship

The Senior Medical Research Fellowship are intended to be amongst the most prestigious awards available to those who wish to continue a career in medical research in Australia. The Fellowship is an integral part of a scheme that is intended to provide both salary and project grant support for outstanding Australian medical researchers. It has a five-year tenure at $275,000 p.a. for a researcher from any discipline in medical science to be awarded in 2022 and commencing in 2023.

Viertel Clinical Investigator awards

$90,000 is available for a clinical researcher who has recently completed their clinical and research training and is commencing their first substantive appointment (appointment of 5 years or more) clinical position or has been in such a post for no more than 36 months on 30 April. Up to five awards available this year.

The Foundation intends to award at least one (1) award to an eligible female candidate in both classes. Only Australian nationals or permanent residents are eligible for these awards.

A reminder that the closing date for both awards is 30 April 2022.

Further information, including eligibility requirements and application forms, is available from The Viertel Charitable Foundation website

Bellberry delivers high quality, timely, professional HREC (Human Research Ethics Committee) services. Our Operations team supports the submission of applications and the delivery of research. The Operations function ensures that Bellberry HRECs can deliver high quality, timely, and consistent research reviews that meet all relevant accreditation requirements. The HREC Officers work closely with the Team Leaders and Operations Manager to deliver a professional, high level support service to our research sites.

We have ongoing opportunities for casual and permanent HREC Officers.

The HREC Officer position description can be found here.

If you wish to apply for this role, please visit the SEEK website.

If you have any queries regarding this role, please contact Athena Seltsikas our HR Business Partner on 08 8361 3222 or email athenaseltsikas@bellberry.com.au.

Bellberry is proud to work with award-winning medical research organisation Linear Clinical Research.

Linear was established in 2010 in WA as part of a vision from the Harry Perkins Institute of Medical Research to provide a purpose built, state-of-the-art, clinical trials facility in the West.

Bellberry has been providing HREC services to Linear since the facility started operating out of the QEII Medical Centre.

To celebrate our relationship, we have created a film highlighting what Linear has delivered to the WA community in bringing world-first clinical trials to the state. Watch the video here.

ACTA has launched a new Industry Partnership Award in recognition of the important role that industry plays in Australian clinical trials.

Open to Members and non-members, the Industry Partnership Award will celebrate a significant collaboration between an industry company and a team of academic investigators uniting to conduct a high-impact clinical trial.

The winner of this new award will be publicly announced at ACTA’s National Tribute and Awards Ceremony, of which Bellberry are premium partners, held in Sydney on 20 May 2022 to coincide with International Clinical Trials Day. The annual awards honour Australians advancing our health system by designing, conducting, or participating in ground-breaking clinical trials and promote the importance of clinical trials and the expertise and complexity of the work involving trial teams, industry partners and consumers.

The closing date for nominations is midnight, Sunday 6 March 2022.

Visit ACTA for further information on the awards and to make your nomination.

Bellberry is delighted to share that one of our HREC members, Greg Crawford, was awarded an AM in the Australia Day honours.

Greg is a Senior Consultant in Palliative Medicine and Director of Research & Education, Northern Adelaide Palliative Service; Professor of Palliative Medicine, Discipline of Medicine, University of Adelaide; Chairman, Board of Palliative Care SA and Chairman, Palliative Care Study Group, Multinational Association for Supportive Care in Cancer.

Greg was awarded the AM for his significant service to palliative care and to tertiary education. Bellberry extend our sincere congratulations on this wonderful achievement.

Hello 2022! Bellberry welcome’s in the new year with 3 HREC meetings being held on 5 January.

HREC meetings will be held every Wednesday for the remainder of the year with the exception of Tuesday 25 January (submission date 12 January) when meetings will be held on this date instead of Wednesday 26 January due to the Australia Day public holiday.

Please contact us at bellberry@bellberry.com.au if you have any submission queries or for any other general queries.

We are delighted to congratulate our CEO, Kylie Sproston, on her election as a Fellow of the Australian Academy of Technology and Engineering (ATSE).

Kylie was elected by her peers along with 26 other candidates for 2021 in recognition of a life-long pursuit of excellence through applied science, technology and engineering.

Chair of MTPConnect, Sue MacLeman said she nominated Kylie because of her leadership in the Australian medical research sector, as well as her role at Bellberry. “Kylie was a strong candidate given her significant contribution to the sector and the work she does more broadly including chairing the CRC Advisory Committee, mentoring our clinical trial researchers and providing leadership,” said Ms MacLeman.

“I think she will provide wonderful skills and expertise to ATSE and will have a real impact participating in policy responses in health and other areas.”

ATSE said the 2021 Fellows “inspire us to be bold, ambitious and progressive in how we use technology to tackle some of our most urgent challenges from COVID-19 to climate change”.

Bellberry is proud to be the premium sponsor of this years Australasian Pharmaceutical Science Association (APSA) annual conference.

The APSA Annual Conference will bring together international and national academics and researchers in the fields of pharmaceutical science, clinical sciences, pharmacy practice, and pharmacy education.

The program will showcase the latest scientific research in each field and offer attendees the opportunity to network with colleagues and other leading international and national scientists and academics at both social and scientific activities. A key feature of the conference will be the chance for early career researchers and students to present their research findings in poster and oral presentation sessions. APSA’s annual awards and prizes will also be presented during the conference.

The virtual conference will take place from 6-8 December. Please click here to register for this event.

Bellberry is proud to be the principal sponsor of the ASCEPT annual scientific meeting taking place virtually next week.

The ASM offers the opportunity to network with colleagues and other leading international and national scientists and academics at both social and scientific activities. A key feature of the ASM is the chance for early career researchers and research students to present their research findings in poster and oral presentations sessions. ASCEPT annual awards and prizes will also be presented at the ASM.

The program of plenary lectures, symposia and workshops, oral presentations and posters look to be scientifically stimulating. We look forward to seeing you online!

As per the National Statement on Ethical Conduct in Human Research (2007) Updated 2018, at the end of each HREC meeting, Bellberry Administration creates a ‘Member List’ as per the example below:

The member composition at the meeting may change from protocol to protocol, in consideration of the expertise required and conflicts of interest. The list is saved on page 7 of your eProtocol application and represents the membership for your protocol.

As outlined in CG P8 HREC Terms of reference, Bellberry does not issue the names of individual HREC members to external parties.

If you have any queries regarding the HREC membership list please contact Bellberry@bellberry.com.au

Bellberry is delighted to once again be a session sponsor at Bio Connections Australia. Bio Connections Australia explores drug development, early phase clinical trials, translational research and expediting Australia’s great science into commercialization. 2020 saw significant disruption to the drug development and clinical trials landscape in Australia and around the world and the research community are keen to reconnect, network, and learn. Bio Connections are excited to be moving back to in-person events but will continue to offer the option to attend the event virtually.

Jerneen Williams, Bellberry Early Phase Clinical Trial Manager will be attending this event and is also a panel member for the session titled ‘Delivering quality and efficiency in Australia’s clinical trials and addressing the resourcing challenge’. Please join Jerneen at this key event!

As most of our users have now formalised local governance processes for internal safety reporting, we have updated MAR G2 Safety reporting, to no longer require the submission of SUSARs for individual events at Bellberry sites.

To assist sites in understanding the updated requirements, if Bellberry’s administrative team receives documentation not outlined in MAR G2, a reference will be made to MAR G2, and the submission returned.

General advice to sites regarding submissions:

If your study is multi-centre, please ensure your submission considers the participants at all centres.

For example:
•   There is a halt in recruitment due to drug supply issues in Australia. The Sponsor has confirmed there will be no supply for three weeks.

Example wording for the site submission:
Our site is awaiting governance sign off and has not recruited any participants. We will not recruit until the halt is lifted.
Dr Peters (site AA) has recruited one participant, and they have enough study drug to last their participant for 6 weeks. If there is any update to the supply issue that puts this participant at risk, we will notify the HREC.

•    If the urgent safety measure includes a request to inform participants of a safety issue:

Example wording for the site submission:
Our site has four active participants. Prof Barnes (site AA) has two participants. All were phoned and told of the safety event and documented in their notes. No participant had any further queries on the matter.

If your study includes a caveat and you are attaching documentation in relation to the caveat, please ensure your submission details the purpose of your attachments.

For example:
•    The caveat on the initial approval letter requests the following “Please submit correspondence from the DSMB during Part A of the trial. Part B cannot proceed until the HREC has reviewed the DSMB letters and an updated PICF and protocol is approved”.

Example wording for the site submission:
The attached DSMB letters refer to the caveat from the HREC on the initial approval letters that all correspondence must be submitted during Part A of the trial. Once the safety letters are acknowledged, the site will submit an amendment for Part B with an updated PICF and Protocol for HREC consideration.

The ‘AER’ safety reporting pathway questions will be updated in eProtocol in due course. Until then sites are welcome to select option 2, ‘Summary report’ for all submissions, as the relevant information regarding dates of events should exist in the attachments.

Please take the time to reflect on the updated reporting requirements and how this will impact your local procedures.

If you have any queries regarding these changes please contact Bellberry at bellberry@bellberry.com.au