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.

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