Phase I Oncology Clinical Trials
In a recent blog, we described the complexity and uniqueness of Phase I clinical trials, outlining the fact that some
IRB
Study Startup Success for BioPharma and MedTech: Engage a Research Compliance Partner
A key element to successful study startup is identifying efficiencies to help meet critical milestones. Engaging with research compliance experts
The State of Clinical Trial Activation at Sites Report
Explore Advarra’s Study Activation Report to uncover roadblocks, survey findings, and solutions to streamline clinical trial activation at sites.
Legislation to Advance Equality and Inclusion in Oncology Clinical Trials
According to the Association for Clinical Oncology, individuals who identify as African American or Black make up 13.4% of the
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
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