Bellberry has been monitoring the development of the COVID-19 outbreak over the last few weeks. As the Australian situation has now moved past the 100 patient point, we would like to share with you information about our planning and services.
Research Participant Welfare & Study Changes
As the COVID-19 situation escalates in a number of jurisdictions around the world and within Australia, many Clinical Trial Sites and Sponsors are considering actions to be taken to protect the welfare of trial Participants and to support the continuation of on-going trials.
Bellberry has developed a list of suggested topics for planning purposes. This list should not be considered to be complete, and additional considerations are likely to emerge as the situation continues to develop. Not every topic will be relevant to every trial. They are however intended to be a helpful starting point when considering planning for individual sites and trial situations. Click here to download.
Operational HREC Activity
The COVID-19 situation has required Bellberry to rethink our Business Continuity Planning, moving from plans that recreate the whole organisation in a new location, to the ways in which we will continue to run our services while the team is wholly dispersed. We have the technology in place to allow this to happen and have been testing fully remote working techniques over the last 2 weeks. These tests cover the executive, the administration, and the function of the HREC, along with the heart of the operation: the HREC meeting itself. We are learning from each series of tests, and are confident that we will be able to continue to offer support and services in the range of possible restricted scenarios ahead.
Bellberry has a schedule of 3 HREC meetings per week, and will continue to support these meetings in a way that protects the safety of our HREC members and operational team.
Business Continuity Planning for HRECs and Institutions
Around the country, health systems are reprioritising their workloads in anticipation of the scenarios ahead. In light of that, a number of institutions have contacted Bellberry requesting information about utilising Bellberry HRECs as a Business Continuity backup for their own HREC.
Bellberry can provide interim support to institutional HRECs and Research Offices: on a long-term, short-term or ad hoc basis.
Please contact Trina O’Donnell, Operations Manager, 08 8361 3222 if you would like more information about this service.
Emergency COVID-19 related Study Reviews
Bellberry has experience of emergency, fast-track reviews of pandemic-related studies. Historically, these reviews have been completed within a few days. Bellberry HRECs also have the depth of experience with routine infectious disease and vaccine studies, such as seasonal flu and diagnostics.
The Bellberry HREC panel includes members with appropriate targeted expertise, including infectious disease, vaccine development, pharmacology, toxicology and immunology. We have confirmed availabilities in the next weeks and months to allow us to support COVID-19 related developments as emergency reviews.
These reviews will be fast-tracked as emergency meetings in addition to the scheduled programme of meetings. We have received contacts about a number of COVID-19 studies, and will play our part in supporting fast-track development. Contact Trina O’Donnell, Operations Manager on 08 8361 3222 for more information.
Bellberry will continue to monitor the emerging situation and will provide regular updates. In the meantime, for any questions, please contact the team at covidsubmissions@bellberry.com.au or 08 8361 3222.