The FDA is collaborating with the CDC to develop a process that would govern how and where to return to on-site facility surveillance inspections in accordance with the gating criteria outlined in the White House Guidelines for Opening Up America Again.

Although inspections are critical, they are one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA regulated products. Safety and quality must be part of the daily routine at any regulated facility for their products to be high quality and reliably suitable for the U.S. consumer.

The FDA is confident in their ability to maintain oversight during this pandemic by leveraging all available authorities, alternative tools, and scientific methods to ensure the integrity and availability of safe and quality products for the American people.

For more details, please see the original communication from FDA.

Meditrial can help – Contact us for immediate support

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:

• Identify patients requiring follow-up
• Conduct investigator and study nurse calls for training to address the situation
• Obtain authorizations for decentralized data collection
• Support to patients for alternative access to needed care
• Prepare procedures and worksheets for remote collection of patient clinical data
• Monitor work instructions and trainings for site support and remote monitoring
• EDC and ePRO solutions to enable study continuity
• Privacy protection measures

Contact Meditrial for immediate assistance in Europe or the US.