The Future of Phase I Oncology Studies
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…
The Noble Pursuit of Investigator-Initiated Research
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.
The Challenge of Unproven Regenerative Stem Cell Therapies
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.
Six Key GDPR Questions to Review
Questions still remain about GDPR and its applications. Have you considered these six key questions to ask within your organization?
Can Ethics Review Catch Up to the CBD Craze?
CBD, a non-psychoactive cannabinoid, is experiencing a massive surge in popularity, but clinical research lags behind in verifying effective uses.
Quorum/Kinetiq Acquisition & Integration:
What You Need to Know
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…
After the Compliance Date: Revised Common Rule FAQs (Or: Why We Cancelled Our February Webinar)
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…
Informed Consent Changes in the Revised Common Rule
Many of the revised Common Rule’s changes aim to make informed consent more meaningful, so that research subjects have the...
Do I Need to Comply With the Revised Common Rule?
Most requirements of the revised Common Rule go into effect January 21, 2019*. While many US researchers are aware of...
Reporting to the IRB: Serious Adverse Events (SAEs) in Drug Studies
At Advarra, we often get questions about exactly what events should be reported to the IRB. We understand that “reportable...
