26 March 2020
Webinar: How COVID-19 is changing the clinical trials landscape
Among the numerous repercussions of the COVID-19 pandemic, life sciences companies and academic medical centers are now faced with significant disruptions and threats to their clinical trials caused by coronavirus and the containment efforts imposed by public and private institutions. Some of the more immediate issues that study sponsors are facing involve travel restrictions, protocol deviations, supply chain disruption, and potential delays or non-performance by vendors.
In this on-demand webinar, representatives from our Global Clinical Trials working group discuss recent guidance from global regulatory authorities spanning the U.S., UK, and Continental Europe and address the following key issues:
- Discussion of issues Hogan Lovells is seeing with clinical trials
- Greater reliance on digital tools to conduct certain study-related tasks remotely
- Increased number of protocol and GCP deviations
- Testing subjects for COVID-19 before and during studies
- Restricted travel to sites for subjects and staff
- Need for additional travel and lodging reimbursement
- Increased costs for conducting studies
- Supply chain disruptions
- Use of expanded access and other pathways to treat COVID-19 with investigational drugs
- Impact on academic medical centers
- Responding to force majeure claims and potential disputes with vendors
For more information, please contact Hein van den Bos.