What Is an Institutional Biosafety Committee?
An Institutional Biosafety Committee (IBC) evaluates risks in gene therapy research to ensure safety and compliance with NIH guidelines. Learn when IBC review is needed.
Reviews
Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
In a recent webinar, Advarra experts Constance Cullity and Michele Russell-Einhorn presented FDA Inspections of Clinical Investigators: Understanding the Process
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
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.
Meridian Builds Robust Gene Therapy Research Program
Discover how Meridian partnered with Advarra to ensure safety and streamline gene therapy research, including swift IBC approvals in just four days.
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
How Sites Can Win in the New Age of Genetically Engineered Treatments
With gene therapy trials on the rise, sites must prepare biosafety protocols, facility standards, and partnerships to attract cutting-edge studies.
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
mRNA and Its Role in Clinical Research
In the race to address the COVID-19 pandemic, researchers have worked tirelessly the past year to produce a vaccine. Operation
Does Warp Speed Vaccine Development and Testing Compromise Safety?
A common trope in sci-fi movies involves concerns about potentially smashing into uncharted objects while traveling at warp speed or