The current COVID-19 Pandemic has affected the conduct and management of clinical studies with the potential to impact future studies. The medical device and IVD clinical research communities, including Sponsors, CROs, study sites, Investigators and IRBs, have been required to flex from their normal study operations and quickly plan and execute clinical studies to avoid any negative bearing on subject safety and integrity.
In this White Paper, we discuss study considerations and ways in which to mitigate risks to help Sponsors navigate challenges related to COVID-19. The best practices and strategies offered within seek to minimize negative impacts to study safety and efficacy endpoints, and allow for continuation of effective clinical study operations during a pandemic.
Areas addressed, include:
- Study Planning
- Database Management/Electronic Data Capture (EDC)
- Site Selection
- Site Start-Up
- Study Execution (Subject Enrollment/Sample Testing)
- Electronic Trial Master File (eTMF)
- Technology and Telemedicine
Please fill out the form below to access this white paper.
We also invite you to learn more about NAMSA’s Clinical Research Services by clicking here.