Considerations for Clinical Study Start-Up in a Virtual Environment
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The impact of the ongoing COVID-19 Pandemic has driven global medical device Sponsors to perform everyday tasks and processes within a virtual setting. This has created several challenges for the device community, not the least of which is clinical trial conduct and management. However, the clinical research community, including Sponsors, CROs, study sites, Investigators and Institutional Review Boards (IRBs), has quickly adapted to a new, virtual environment to reduce potential negative impacts on subject safety and study integrity.
This virtual presentation and discussion reviews best practices and strategies to mitigate risk, minimize timeline impacts, increase site engagement and boost quality of remote clinical study management.
Participants will leave with a better understanding of:
- Protocol and supporting documentation development
- How a virtual environment increases flexibility
- Communication considerations between sites, Sponsors and CROs
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