Impact of COVID-19 on the Life Sciences Industry
- Note: This post was last updated on May 25, 2020.
Welocalize Life Sciences is actively tracking the impact of COVID-19 on the life sciences industry around the world. Check back here regularly for updates on the impact of COVID-19 on clinical trials, EU MDR, telehealth, and more.
Clinical trial sponsors and CROs are racing to develop vaccines and treatments for COVID-19. Cytel Inc. has launched an open-access global COVID-19 Clinical Trial Tracker to help facilitate greater collaboration between critical stakeholders involved in tackling the COVID-19 outbreak.
Cytel is proud to launch a global COVID-19 Clinical Trial Tracker. The tracker will help facilitate greater collaboration to understand the global response to the COVID-19 outbreak. Click here to explore the tracker: https://t.co/eaZhXbKxMo #covid19trialtracker #covid19 pic.twitter.com/TKyLBdEl6s
— Cytel Inc. (@cytel) April 9, 2020
The COVID-19 pandemic may impact the conduct of existing clinical trials. Challenges range from site closures to travel limitations to interruptions in the supply chain. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently released guidance for conducting clinical trials during the pandemic.
VIRTUAL CLINICAL TRIALS
In late March, both the Food and Drug Administration and the European Medicines Agency published guidance documents that called out the use of telemedicine and virtual visits as vital tools to ensure safety for patients already enrolled in clinical trials, and as a mechanism by which drug development continuity could be provided.
Please also access these relevant COVID-19 resources and databases:
- ClinicalTrials.gov: Federally-funded clinical studies related to COVID-19
- WHO Trial Registry Network: COVID-19 studies from the ICTRP database
- CDC: Information for Clinicians on Therapeutic Options for COVID-19 Patients
- NIH: https://www.nih.gov/health-information/coronavirus
- EU: https://www.clinicaltrialsregister.eu/ctr-search/search?query=covid-19
DRUG + DEVICE PATENT FILING
Work has been suspended at many local patent offices. Agents can still file electronically via the online system, where available. However, deadlines that fall within this time period are automatically extended until the first working day when the patent office resumes normal operations. Park IP & Legal, a Welocalize company, is monitoring local notifications and continue to provide updates here, as they become available. For information related to pharmaceutical and medical device patent translation and filing, contact us.
(NEW) Medical Devices
Due to COVID-19, the European Parliament has voted to delay implementation of Medical Devices Regulation (MDR) by one year to prevent shortages or delays in getting key medical devices on the market. Parliament adopted the Commission proposal on Friday, 17 April, by urgent procedure with 693 votes to 1 and 2 abstentions, allowing the application of the Medical Devices Regulation to be postponed by one year until 26 May 2021.
The likelihood of regulatory delays due to COVID-19 pandemic is high, according to a poll conducted by Verdict. The guidance documents published by the FDA, EMA and MHRA in the above Clinical Trials section provide information related to potential regulatory delays.
INTERPRETING SERVICES + TELEHEALTH
(NEW) Patient Satisfaction with Telehealth
COVID-19 has fueled the rise of telemedicine. According to a new, large-scale Press Ganey survey, patients are as satisfied with virtual interactions as they are with in-person encounters. “Based on the data, patients are overwhelmingly positive about their virtual interactions with their care providers, even when technical issues posed challenges,” according to The Rapid Transition to Telemedicine: Insights and Early Trends, issued by Press Ganey.
Where in the past, Welocalize Life Sciences has supplied hundreds of onsite interpreters for language services ranging from patient/provider communications to investigator meetings, the demand has shifted to requests for remote interpreters. We have partnered with industry leaders to ensure our medical interpreters are up to speed on the different platforms and system requirements for our selected Remote Simultaneous Interpreting and Over-the-Phone/Video Remote Interpreting platforms, in over 200 languages.
During this pandemic, our teams have worked with many clients that have required rapid turnaround of all types of multilingual content, including e-learning, eConsent forms, patient tutorials, telehealth services, and more. How can Welocalize Life Sciences help your team manage its language services needs in a remote environment? Contact us.