The FDA has posted a new “At-a-Glance Summary” that captures the agency’s major activities in the fight against COVID-19.
The FDA has made a wide range of information regarding their activities available to the public on their COVID19 website. This includes regularly updating our Frequently Asked Questions in both English and Spanish. It also includes issuing a number of Consumer Updates, MedWatch alerts, stakeholder updates, webinars, and other resources, including for patients and health care providers.
The agency intends to regularly update this resource on efforts related to medical products and equipment, vaccines and therapeutics, food supply and more.
For more details, please see the official communication from FDA.
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
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