The COVID-19 lockdown compelled clinical trial managers and regulatory compliance officers to innovate in ensuring that critical testing moved forward while the world had shut down.
With life shifting back, how much of these new measures will remain in place?
Join us on Tuesday, May 18 on DeviceTalks Tuesdays to hear representatives from Medtronic, Hologic and other leaders share how they responded to the shifting sands of the COVID-19 lockdown.
The discussion – What’s Now and What’s Next: Hybrid Approaches to Clinical Trial Oversight – is sponsored by IMARC Research.
The response to COVID-19 actually brought the industry into compliance with the FDA’s support of risk-based oversight. The industry had been slow to respond to the 2013 guidance.
But the 2020 pandemic changed all that, catapulting the industry into acceptance of various remote strategies to clinical trial oversight in order to just survive, according to IMARC. The session will look at what the industry is doing now to meet FDA expectations and collect patient data in the safest and fastest way possible.
Topics to be covered include
- Has the quality of clinical trial oversight been impacted due to the pandemic?
- Have sponsors and/or sites realized a cost difference with more activities being done remotely?
- How has technology stepped in to fill the gap this year?
- Will running a clinical trial ever go back to “business as usual”?
- How do you determine how to design your “hybrid” approach to running a clinical trial?
The panel of experts includes
- Xavier Lefebvre, Global VP Medical & Regulatory Operations, Medtronic
- Eric Kolodziej, Corporate VP, Global Head of Quality and Regulatory Affairs, Hologic
- Brandy Chittester, President, IMARC Research
- Hamish Baird, Clinical Research President, Remington-Davis Inc.
Register for tomorrow’s session here.