COVID-19 Resources and Services from WCG:
COVID-19 Webinar Series
Watch the WCG COVID-19 Webinar Series On-Demand
Join thousands of your peers in watching WCG’s webinar series, where clinical trial and public health experts provide the insights on COVID-19 and discuss the biggest questions and topics you submit.
COVID-19 Trial Insights from the WCG Knowledge Base™
About WCG Trial Insights
The WCG Trial Insights series brings you weekly insights on trial activity throughout the COVID-19 crisis, based on the extensive services we provide to life science clients and supported by our proprietary and powerful WCG Knowledge Base™.
WCG COVID-19 Advisory Services
Need help interpreting critical data to navigate the impact of COVID-19 on trials and sites? We leverage insights and benchmark data from the WCG Knowledge Base to guide best practices for trial performance during this unprecedented time.
Insights from June 11, 2021
Recent Insights from WCG
Watch Recent COVID-19 Webinars
Recent news on COVID-19 and clinical trials
News provided by WCG FDAnews and WCG CenterWatch
FDA Withdraws Authorization for Last Remaining COVID-19 Monoclonal Antibody Treatment
Three drugs are still recommended for treatment, along with convalescent plasma.
NICE Rejects Five Treatments for COVID-19
The drugs were rejected because of the high uncertainty of effectiveness against the Omicron variant.
FDA Grants Sobi Emergency Authorization for Kineret to Treat COVID-19
The EUA was based on positive results from a phase 3 study.
FDA Redefines Face-to-Face Meetings to Include Virtual Option
The FDA is changing its definition of face-to-face meetings to clarify that they include both in-person meetings and virtual meetings on audio- and video-enabled platforms. But at the moment it won’t be holding in-person meetings.
Senzo Partners with BARDA over Amplified COVID-19 Antigen Test
The antigen test was 100 percent accurate when compared with PCR testing, even in cases with very low viral levels, the company said.
FDA Clarifies Advertising and Marketing Rules for Certain COVID-19 Drugs
Companies must submit materials to the FDA 14 days in advance so the agency can provide feedback.
Roche’s Cobas Qualitative PCR COVID-19 Test Gets 510(k) Clearance
“Based on continuous analysis performed since the onset of the pandemic,” the tests detect all variants of the SARS-CoV-2 virus, Roche said.
Aptitude Medical’s Metrix COVID-19 Test Authorized
The test results do not rule out co-infection with other viruses or bacteria, the FDA said.
Novavax Gains EUA for Adjuvanted COVID-19 Booster Vaccine
The EUA decision was based on positive results from two studies.
FDA Offers Update on Jiangsu Well Biotech Recall
No complaints or reports of injuries or deaths have been associated with the recalled tests, the agency said.
Roche’s COVID-19 Rapid Tests Gain CE Marks
The company plans European distribution of the new rapid tests within weeks.
Fujifilm Ends Avigan Flu Drug Development for COVID-19
The trial aimed to include 316 participants with early-onset COVID-19 but was halted in March with just 84 patients enrolled.
Expert insights on clinical trials and COVID-19
As we navigate COVID-19 together, our clinical trial experts are engaged to address the biggest questions. To submit a topic or question, use the form at the bottom of the page.
Submit a COVID-19 question or topic to be considered in future webinars
Please note: protocol-specific questions for studies under the oversight of a WCG IRB should be submitted through your IRB contact person, not through this form.
Disclaimer: All information available on this site is intended for your general knowledge and is not for the purpose of providing regulatory advice, medical advice, or a substitute for institutional review board review. You should not use this information to determine compliance with any applicable laws or regulations governing institutional review boards and human subjects research.