Considerations for Ensuring Trial Continuity in the Wake of COVID-19
We’ve gathered questions from our customers and vendors regarding potential impact of COVID-19 on current and planned studies. Although we may not have answers for every situation, here are some areas that we are keenly focused on to support our sponsors:
- Talk to your CRO about CRA travel limitations and impact to on-site site qualification visits and investigator meetings.
- Assess the number of patients currently enrolled and unable to travel.
- Consider alternative monitoring strategies such as remote monitoring and centralized monitoring.
- Maintain communications with sites.
- Actively review and assess risk at the site level.
- Arrange to have investigational products (IP) shipped from pharmacy to home, if allowable under current regulations.
- Monitor your entire supply chain.
- Consider meetings with regulators, ethics committees, and IRB.
- Plan for any impact on business continuity and ensure employees are able to work virtually.
- Assess database lock impact to current studies.
For more information on Premier’s capabilities, click here.
Other Premier resources: https://premier-research.com/tag/covid-19/
Please visit the links below for more important information on COVID-19:
- EMA Guidance to Sponsors on How to Manage Clinical Trials During the COVID-19 Pandemic
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
- MHRA Advice for Management of Clinical Trials in Relation to Coronavirus
- Seven Steps to Protect Yourself and Others from COVID-19
- ACRO’s Recommendations to Support Monitoring Oversight During COVID-19