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August 29th, 2021
Update from our CEO, John Moller, on Coronavirus (COVID-19)
Dear Novotech Partner,
I want to provide you with an update outlining Novotech’s response to the COVID-19 situation as at 29th August 2021.
COVID-19 planning is an important part of our weekly Executive Committee meeting, and a COVID-19 group meets regularly to focus on relevant issues to ensure:
- We minimize risks in our working environment
- Staff are able to work remotely
- Travel advice is regularly reviewed
- We understand site impacts and can create contingency plans for our clients
- We understand impacts in relation to regulatory authorities, ethics committees, importation authorities etc.
The Board also has a COVID-19 subcommittee. This includes Dr Fred Cohen who was involved in advising TPG companies during SARS.
- We have suspended international business travel across the company. Domestic travel requires special approval.
- We have equipped our offices with surface and hand sanitizers and implemented social distancing measures.
- We have offered all staff influenza vaccinations to minimize risks of dual exposure, particularly recognizing the upcoming southern hemisphere flu season.
- Novotech has a business continuity plan (BCP) that forms part of our quality system.
- We stress tested of this plan including rolling zero-notice 24-hour office closures in early March, resulting in a number of changes to improve staff ability to work from home.
- We implemented work from home across the company in mid-March although staff continue to have access to the offices e.g. for paper file access.
- All Novotech staff have laptops and can work from home. All of our systems are cloud-based and we have recently received ISO 27001 Information Security certification.
- We maintain a register of any issues with site availability, and project managers have contingency plans in the event of site closures. Our experience in Asia has been that while sites may temporarily close during an increase in COVID-19 cases, health systems may designate selected hospitals or sites to COVID-19 care allowing key trial sites to stay open.
- Our local country staff maintain a register so that we can understand impacts in relation to regulatory authorities, ethics committees, importation authorities etc.
- Novotech’s remote monitoring SOP has been updated. We maintain a register of the approach taken by each country to remote monitoring. Health authorities in Asia are taking a pragmatic response, and the regulatory authorities and sites are increasingly allowing remote monitoring.
- We have applied for “essential service” designation in many of our countries to ensure site access in the event of national lock downs.
- We are talking to our conference providers to understand their remote conference capabilities as we expect that a number of meetings will need to change format e.g. investigator meetings.
COVID-19 project support:
- Novotech is well placed to support COVID-19 trials and we are currently working with a number of clients across a range of therapeutic approaches and levels of disease severity.
- We are working closely with regulatory authorities, ECs and KOLs to ensure accelerated approval and initiation of these trials.