Q&A: Institutional Responsibilities Under a Federalwide Assurance
In a recent webinar, Advarra regulatory experts presented on the topic titled Institutional Responsibilities Under a Federalwide Assurance (FWA). Our
IRB
Understanding the Complexity and Uniqueness of Phase I Trials
In clinical research, working with organizations that understand the ins and outs of the phase of your trial is key
Top 10 Educational Resources of 2020
It’s safe to say 2020 has been more unpredictable than anyone could imagine. Through these unprecedented times, we have worked to provide the
New FDA Certificate of Confidentiality Guidance: What Does it Mean for You?
FDA has recently issued guidance relating to changes for Certificates of Confidentiality (CoCs) brought about by the 21st Century Cures
Community-Based Participatory Research (CBPR): A Framework for Community Engagement
Community-based participatory research (CBPR) continues to come up in conversations surrounding diversity and inclusion in clinical research. This specialized method
The Many Faces of “Coercion” and “Undue Influence”
The United States regulations governing research with humans pay special attention to two ethical concepts that may not be familiar
Q&A – Racial Diversity in Clinical Trials: Building Trust in Participant Engagement
In our latest webinar, a panel of experts from research organizations, Community Health Centers (CHCs) and healthcare tech discussed racial
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
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.
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