CRO
The Future of Phase I Oncology Studies
Oncology drugs in phase I trials are usually conducted on patients with cancer due to their inherent risk. Advarra IRB member Ran Goldman expands:
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.
After the Compliance Date: Revised Common Rule FAQs (Or: Why We Cancelled Our February Webinar)
We have cancelled our webinar “After the Compliance Date: Revised Common Rule FAQs,” which was originally scheduled for February 28.
Informed Consent Changes in the Revised Common Rule
If your research must comply with the revised Common Rule, you’ll need to update the way you write ICFs to meet the new requirements.
Do I Need to Comply With the Revised Common Rule?
While many US researchers are aware of the coming Common Rule changes, not everyone is sure whether they will need to comply with the revised regulations.
Infection Control and Biosafety in Gene Therapy Research
Given the growth in gene therapy research, sponsors, CROs and sites have become increasingly curious about the requirements to be able to conduct such studies.
Integration Update: Leading Compliance Adherence
The Advarra team is proud to announce that all major integration activities are now complete.
ICH-GCP Guidelines and Research Conducted in the US
Learn the basics of how ICH-GCP Guidelines can impact the study ICF and how we at Advarra came to our updated policy on the topic.
What’s the Difference Between Right to Try and Expanded Access?
Let’s take a look at the basics of what each program does and does not do for patients seeking to access investigational therapies.