CSOFT Health Sciences and Professor Victoria Elegant convened for another conversation after interviewing her for Women’s day (here). She has been actively involved in managing the COVID-19 pandemic situation with her staff. She recently was a panelist on a MAPS webinar on the Coronavirus.
This time, we warmly welcome back Professor Elegant to discuss global cooperation, the pandemic’s impact on clinical trials, and her insights for our future in moving forward during a pandemic.
Dr. Hope: To start off, what are your thoughts on the need for cooperation globally? How has the pandemic highlighted this necessity?
Professor Elegant: Global cooperation is absolutely essential in this current situation. The virus does not respect hierarchy, borders, or income and has been infecting everyone from senior politicians and movie stars to the elderly and the homeless. There are no geographical boundaries so there has to be global cooperation to find solutions both short and long term. This includes therapies and vaccines – both need global research to be successful and timely, including equitable distribution globally – and cooperation moving forward about how to manage non-pharmaceutical interventions, travel, and a host of other areas which will change in the new normal.
Dr. Hope: Has the pandemic made an impact on clinical trials? What has that been like?
Professor Elegant: Many companies have had to prioritize their portfolios in the light of the restrictions on clinical trials – sites pausing trials, pausing on-site monitoring or source-data verification (SDV), wanting to be respectful of investigators who are busy treating patients with COVID-19, protecting staff, and supporting patients. The pauses have of course had a potential impact on regulatory timelines. Teams have come up with creative solutions to help patients such as home delivery of clinical trial supplies. Also, the regulators in some countries allowed remote SDV to minimize impact on timelines. The teams have worked almost 24/7 in order to manage the rapidly changing and challenging situation and to safeguard patients as well as work with investigators. In Asia, we are starting to see the situation improve and stabilize.
Dr. Hope: Congratulations on your panel-ship on the recent MAPS webinar. Do you have any insights from that which you’d like to share?
Professor Elegant: Thanks so much! The situation is fluid, rapidly changing, and requires us all to excel in dealing with ambiguity and change alongside being exceptionally adaptable. In the medical field, the focus on what is best for patients acts as a true North Star to guide in these difficult times. Digital and virtual solutions are reshaping the healthcare landscape and will be with us in some shape or form in the new normal, and we will all need to understand and work in flexible ways to meet the needs of patients and healthcare professionals. Finally, this is a marathon and not a sprint, so everyone needs to look after themselves and their families.
Wise words. CSOFT Health Sciences thanks Professor Elegant for her time in responding to COVID-19 related questions in these challenging times. As we consider what is best for ourselves, our families, and patients everywhere, it is important to remember to hold hope close for a better tomorrow, as we work together to create a better, healthier world.
- Dr. Hope
About CSOFT Health Sciences
CSOFT Health Sciences provides end-to-end medical translations for all phases of the product lifecycle, from pre-clinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.
CSOFT International is a leading provider of cross-border communications for enterprises seeking growth in global markets. Our expertise in localization, documentation, and branding encompasses a full range of end-to-end content and consulting services that we deliver in over 250 languages. With a focus in health sciences and smart technology, we work closely with our clients to deliver precision solutions to the challenges of engaging markets, consumers, and regulatory environments worldwide.
Dr. Hope is not a doctor but a creative voice at CSOFT Health Sciences, who seeks to provide insightful, factual, and relevant explanations of phenomena in the medical industry. Sometimes historical, other times philosophical, and generally related to the scientific interest and well-being of society, Dr. Hope provides commentary, inspiration and hope to readers thinking about health in the big-picture. You should not rely on this information as a substitute for, nor does it replace, professional medical advice, diagnosis, or treatment.