Category: <span>Education and Resources</span>

Bio Connections Australia explores drug development, early phase clinical trials, translational research and expediting Australia’s great science into commercialization. It comes at a critical time for Australia’s medical research sector. The focus of the agenda this year will be on translation and commercialization of homegrown Australian research, improving drug development and clinical trials in Australia as well as the impact of COVID-19 on the landscape.

Bellberry is proud to be silver virtual exhibitors at this year’s event with Leanne Weekes, CT:IQ Program Director attending as a speaker.

Click here to register for this event

In 2020 COSA are moving away from their tradition of focussing on one or two cancers, and featuring Quality & Safety, Implementation Science and Cardio-oncology as program themes which will provide something for everyone in their multi-disciplinary membership.

Bellberry board member Professor Ian Frazer AC will be presenting a live virtual session on Friday 13th Nov entitled ‘Cancer Immunotherapy – what have we learnt since the time of Coley?’

To register for this event visit the COSA website.

 

As part of our continuous improvement process, Bellberry has introduced a Batch Processing pathway.  This pathway aims to ease the burden on sites and sponsors. The batch submission pathway enables:

Completing and submitting the batch form (MAR F8.1.1) grants Bellberry the authority to process submissions in eProtocol on behalf of the Investigator. Before completing this form, the requestor must ensure they have discussed the submission with the relevant sites/sponsor to avoid duplication of work. Following this, our standard procedure of review and decision outcome will take place.

Since March 2020, the Bellberry team and our HRECs have processed over 60 batch submissions accounting for over 540 individual amendments. This is an extraordinary reduction of 480 individual amendments that would otherwise have required Site resourcing.

Please note, Bellberry’s dedicated batch submission team will acknowledge receipt of your batch request within 48 hours of receipt.

If you have not received acknowledgement of your batch request within 48 hours, please contact Bellberry on 08 8361 3222.

For further information please refer to MAR G8 Batch submissions

CT:IQ is pleased to launch a series of use cases illustrating successful implementation of eConsent in Australia, aimed to be used as a guide for researchers and HRECs seeking to develop and implement eConsent.

In 2019, Chrysalis Advisory, on behalf of CT:IQ, undertook an investigation of stakeholder opinions about the benefits, risks and critical success factors for eConsent implementation, published in a 2019 report. A summary of this report has now been published as a perspective in the MJA.

Following on from this work, the need for use cases to demonstrate practical implementation of eConsent was identified and subsequently developed. The examples, which can now be accessed via the CT:IQ website, show that the use of eConsent is acceptable to HRECs and institutions and should be treated no differently to standard consent processes.

“Our review of use cases revealed that use of digital platforms clearly and unequivocally enhance the informed consent process and are equally if not more acceptable than traditional methods,” says Professor Nik Zeps from Chrysalis Advisory.

There are currently three use cases featured, including the Australian Genomics Health Alliance, Royal North Shore Hospital and Murdoch Children’s Research Institute that demonstrate:

CT:IQ will continue to provide updates as the bank of use cases on the website grows over the next few months.

Bellberry is one of the four founding members and a proud supporter of CT:IQ.

Bellberry is committed to ensuring the privacy and security for users of our service. In light of recent government announcements warning of increases in cybersecurity attacks, Bellberry has assessed its current processes relating to eProtocol registrations and have made the following changes to strengthen our current security procedures.

All new eProtocol registrations will be required to submit an Organisational Verification of Personnel form (OVOP BA F2.1.3). This form replaces all previous authorisation forms, and its purpose is to verify the new applicant’s affiliation to the organisation/site with which they are registering. Each site will need to appoint an authorised representative that will sign off each new registration for their organisation on the OVOP form.

What is an authorised representative?

Each organisation must have a dedicated person(s) that assumes responsibility for the authorisation of new personnel registering for eProtocol access from that organisation. The authorised representative should be known by staff as they will need to verify the applicant as part of the registration process.

Larger organisations may choose to delegate this role to a departmental level, e.g. a hospital may select the Clinical Trials Manager in each department. For stand-alone clinics, it may be the practice manager or Principal Investigator. The organisation is responsible for determining the person responsible and declaring this person to Bellberry. Bellberry will maintain a register of authorised representatives, and each new registration for that organisation will be verified with the nominated representative.

Sites and sponsors will notice the change to new registrations from August 14 2020. There will be no change for existing registrations.

For any eProtocol registration related questions, please contact our HREC Co-Ordinator, Alison Branford, on (08)  8361 3222 or via email bellberry@bellberry.com.au.

Related documents

For comprehensive guidance on Bellberry’s eProtocol registration requirements, please see BA F2.1.3 Organisational Verification of Personnel form

Disruption, adaption and adoption

The COVID-19 pandemic has rapidly transformed much of the clinical trials and associated medical device, pharmaceutical, and vaccine industries in Australia and internationally.

What’s next for the world of clinical research as we learn to adapt to the changes which are likely to remain with us long term as a result of the Covid19 pandemic?  

Sponsors, contract research organisations, and sites are now focusing on returning to full capacity. Changes in practice mean that “business as usual” will be disrupted. Many positive changes will arise – and that’s a significant positive outcome arising from the pandemic, but what does this mean for our usual practice? 

During this webinar hosted by PRAXIS Australia, we will hear from sector leaders who will address ethical, practical and clinical implications relating to the new health and safety concerns for patients and employees and learn about their experience with solutions to those problems, such as telemedicine/telehealth, direct-to-patient approaches, and implementation of new site level technology to ensure safety measures are properly in place.

Date: 20th August
Time: 11am – 12:30pm AEST
Price: Free of charge

Facilitators: 

Other panellists: 

COVID-19 FAQ

As Bellberry’s position has changed significantly since 2020, please direct your COVID-19 queries to bellberry@belberry.com.au. We’re here to help.

ACTA, PRAXIS, ARCS and CT:IQ collaborate to host clinical trials online forum launching on International Clinical Trials Day, 20 May 2020

Australian Clinical Trials Alliance (ACTA), PRAXIS Australia, ARCS Australia and CT:IQ have come together to create Beyond COVID-19: a solution-focussed forum after identifying a need for the clinical trial sector to collaborate and share information.

Beyond COVID-19: a solution-focussed forum is an exciting new initiative for people working in clinical trials to share their learnings and assist with solutions.

It will be open for anyone to read, and registration to participate is simple. Clinical trialist’s can instantly share their knowledge, assist with responses and point each other to useful resources or contacts; from ethics to telehealth, pharmaceutical supply to remote monitoring. Solving problems is at the heart of clinical trials, and the COVID-19 pandemic has seen the sector becoming more agile; adapting existing trials, finding new ways to commence planned trials, or moving quickly to help test treatments and solve the riddles of coronavirus.

The pathway out of the pandemic will also see some twists and turns and more problem-solving for the sector, where the Beyond COVID-19: a solution-focussed forum will continue to be a sharing space.

Join us all at 1:30 pm AEST on International Clinical Trials Day, Wednesday 20 May, for the official launch of Beyond COVID-19: a solution-focussed forum.

A guest panel of experts will be live on the forum for the launch to offer their perspectives on your questions about clinical trials through COVID-19 and beyond.

Please register beforehand – today.

The forum will be hosted at clinicaltrialsalliance.org.au/forums/

#clinicaltrials #COVID19 #BEYONDCOVID19

Report of an international workshop convened by Bellberry, held on November 18-20, in Sydney, Australia

In November 2019 Bellberry were delighted to host the “Challenges of Valuing and paying for Combination Therapies in Oncology” international workshop in Sydney.

This event brought together over 50 experts from around the world from a range of stakeholder groups to discuss the challenges associated with valuing and paying for combination regimens in oncology. All aspects of the workshop programme were overseen by a Scientific Committee and were chaired by E/Prof Lloyd Sansom.

The workshop was followed by a one-day open day meeting where the deliberations and conclusions of the expert panel presented and debated amongst a wider local audience.  The workshop outcome was the development of an agreed statement of good practice, guidelines on approaches and a clear agreement on any required next steps.

The full workshop report can be viewed here

Earlier this week Bellberry CEO Kylie Sproston joined Tam Nguyen (St Vincent’s Hospital Melbourne) and James Cokayne (NSW Health) to speak at one of ARCS Australia’s series of webinars on COVID-19.

The session was entitled ‘Ethics Committees and Governance’ and topics discussed by the panel included how to manage the continuation of the safety and welfare of participants during the pandemic along with tips on how to best manage your trial during this time.

The full webinar can be viewed here.

ENROL NOW!

PRAXIS’s small team has received over 1000 enrolments for these sessions and as such processing of registrations may be prolonged. It’s likely that PRAXIS will need to plan new dates so please visit the PRAXIS website regularly!

25 – 29 November, Queenstown, NZ

‘Shared horizons: Optimising drug response to improve patient outcomes’

The Meeting 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 Meeting is the chance for early career researchers and research students to present their research findings in poster and oral presentations sessions. ASCEPT-PAGANZ annual awards and prizes will also be presented at the Meeting. The program of plenary lectures, symposia and workshops, oral presentations and posters will be scientifically stimulating and lead to new collaborations and research opportunities. Bellberry are delighted to be a major meeting sponsor of this event and we look forward to seeing you there. For further information please visit the ASCEPT-PAGANZ event website.

Last week at the AAHMS 5th Annual General Meeting the Academy admitted 40 new Fellows in recognition of their outstanding contributions to the health and medical research landscape in Australia. In addition, the Academy has elected two global research leaders as Corresponding Fellows.

The Australian Academy of Health and Medical Sciences also launched its first honorific award, the Jian Zhou Medal, which will be awarded annually to a rising star of Australian health and medical science. The Medal is named in honour of late Dr Jian Zhou, a talented molecular biologist and virologist, who worked with Professor Ian Frazer AC to develop and patent the technology underpinning the Gardasil and Cervarix vaccines, which protect women worldwide against viruses that cause cervical cancer.

The Medal will recognise an individual who is making a significant impact in translational medical science, primarily working in Australia. The recipient will be a postdoctoral researcher within 15 years of achieving their PhD (or equivalent first research higher degree) and nominations are welcome from all fields associated with furthering biomedical and health research, whether clinical or basic biomedical research, but must have a clear translational focus.

For more information on the Medal and how to nominate a candidate, please visit the AAHMS website.

The Annual General Meeting was a resounding success and Bellberry were proud to be in attendance as well as a Platinum sponsor of the event.

Bellberry is delighted to be both sponsoring and exhibiting at this years ACTA International Clinical Trials Conference, 2 – 5 October, Sydney.

The conference brings together Australian and international experts in the cutting-edge design and conduct of clinical trials and registry custodianship, healthcare funding, policy and regulation, health care service delivery, health information technology, health economics and patient advocacy.

The Conference theme is ACTA’s reason for being – Better Health Through Best Evidence – providing a platform for national and international stakeholders to share global advances in the development of self-improving healthcare systems.

The program will address:

Bellberry is proud to be a part of this valuable event which is integral to the advancement of clinical trials research in Australia and internationally. We look forward to seeing you there!

Find out more and register on the conference website

CT:IQ Webinar: Wednesday 18 September 2019, 13:00 – 14:00 (ACST)

Click here to enrol: http://praxisaustralia.com.au/enrol-now 

CT:IQ is MTPConnect and member-funded Clinical Trials sector improvement initiative with government support from the TGA, PBAC, MSAC, NHMRC and the Office of Health & Medical Research within the Department of Health.

CT:IQ’s mission is to develop and implement recommendations that will improve the impact, quality and efficiency of clinical trials, leading to more rapid, lower cost and higher quality evaluation of healthcare interventions in Australia – our mission is to get Australia Thinking Smarter about the conduct of clinical trials!

CT:IQ’s vision is to act as a platform for all stakeholder voices to come together.  CT:IQ’s membership is comprised of 40 diverse organisations with national and international representation from government, pharma, device organisations, CROs, academia, medical research institutes, phase 1 units, CTNs, advocacy groups and consumer representatives.  CT:IQ is the only initiative where government and clinical trial stakeholders in both investigator-led and industry trials sectors can come together to undertake meaningful sector improvement initiatives.  This will lead to a more meaningful integration of clinical trials into the Australian health care system, resulting in better healthcare and better outcomes for patients, participants and the community.

CT:IQ are conducing five projects in 2019 selected and prioritised against the needs of the sector by our Steering Committee members in the following areas:

During this webinar CT:IQ Director Leanne Weekes, will provide updates on all five 2019 projects.

This interactive session will also be an opportunity to ask questions and find out more about CT:IQ and how to get involved.

The CT:IQ Steering Committee has a small number of remaining seats therefore your participation is a rare opportunity for your organisation to have a voice.

ClinTrial Refer Webinar: Tues 24 September, 11:00 – 12:00

Click here for further information on the ClinTrial Refer Webinar (scroll to the bottom of the page)