Surprise! “Checking the Box” Is Still an Option on the Federalwide Assurance (FWA)
The Common Rule (subpart A of 45 CFR part 46) requires that each institution engaged in nonexempt human subjects research
Reviews
Takeaways From the FDA’s VRBPAC Meeting – October 22, 2020
As part of FDA’s response to combat COVID-19, FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC). The
By the Numbers: Our Response to COVID-19
We are honored to support a resilient research community during the COVID-19 pandemic. See the data points in our infographic to find out how Advarra helps keep research moving forward.
Q&A – Study Startup Success for the New Generation of Genetically Engineered Vaccines
In a recent webinar, Advarra Executive Director of Biosafety Services Daniel Eisenman discussed the latest trends in genetically modified vaccine and immunotherapy studies. He also explored unique startup challenges for studies involving investigational products that contain engineered genetic materials. Due to time constraints he wasn’t able to answer all audience questions during the Q&A period, so he has answered some of the most popular questions in this blog.
Beginner’s Guide to Investigator-Initiated Trials
While many clinical trials are initiated by industry sponsors, such as pharmaceutical companies or contract research organizations (CROs), other trials
Racial Diversity in Clinical Trials: Building Trust in Participant Engagement
Racial Diversity in Clinical Trials: Building Trust in Participant Engagement While racial and ethnic diversity in clinical trial participation has
The Critical Role Sites Play in the Evolution of Clinical Trials
Drawing on the perspectives of experts from Parexel and Advarra, this white paper explores the evolving role of technology in clinical research and its impact on research sites and study conduct.
Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements
In a recent webinar, Advarra regulatory experts discussed the must-haves of FDA and Common Rule reporting requirements. They reviewed the basics of what must be reported to whom—and when—for sponsors and investigators involved in IND studies, as well as requirements for identifying, reviewing, and reporting unanticipated problems and noncompliance to IRBs and Common Rule departments or agencies. Due to time constraints we weren’t able to answer all audience questions during the Q&A period, so our experts have answered some of the most popular questions in this blog.
Global CRO Drives Study Startup Efficiency by Converting Local IRB Sites to Central IRB Review
Discover how Advarra helped a global CRO streamline site management, cut activation times, and improve cost efficiency through central IRB review.
Q&A – The New Urgency of Clinical Trials: How Oncology Leads the Evolution
In Advarra’s recent virtual symposium, experts from industry and academia met to discuss how oncology research has influenced agility in clinical trial design, particularly during the COVID-19 pandemic. Panelists talked about how the COVID-19 pandemic has impacted oncology research and propelled the field’s groundbreaking contributions to research. They also explored ways the pandemic response has shaped the future of oncology research—and research in general.
Getting “Engaged” in the Time of COVID
When using remote sites to perform clinical trial procedures, there are certain issues researchers must keep in mind, including whether those remote sites are considered to be engaged in research.
Community Consultation in the Time of COVID-19
How should sites conducting planned emergency research approach community consultation in the time of COVID-19?