Phase I studies in oncology pose challenges unlike any other early phase study. Most phase I studies begin with healthy volunteers, but because of the unique nature of the trial compounds, participants in oncology phase I studies are typically patients with cancer rather than healthy volunteers.
Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.
Questions still remain about GDPR and its applications. Have you considered these six key questions to ask within your organization?
CBD, a non-psychoactive cannabinoid, is experiencing a massive surge in popularity, but clinical research lags behind in verifying effective uses.
On March 5, 2019, Advarra announced its acquisition of Quorum Review IRB and Kinetiq, the research and technology consulting division of Quorum. We’ve assembled this FAQ to address some of the most commonly asked questions about the acquisition and integration.
The bad news is we cancelled our webinar on the revised Common Rule. The good news? We cancelled it because it seems the revised Common Rule implementation and transition have actually been relatively smooth.
Many of the revised Common Rule’s changes aim to make informed consent more meaningful, so that research subjects have the
Most requirements of the revised Common Rule go into effect January 21, 2019*. While many US researchers are aware of
Gene therapy research has moved from the realm of science fiction to mainstream clinical research. The maturation of this field
The Advarra team is proud to announce that all major integration activities are now complete. SOPs have been harmonized; staff
When research is being conducted in multiple countries, determining which regulations apply to which country’s sites can sometimes be complicated.
The right to try movement and recent passage of the federal right to try law have renewed public interest in
