Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
In this blog, we’ll take a look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”
centralized review
How Centralized IBC Review Can Benefit Gene Therapy Research
Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements here.
Local Versus Central IRBs: What’s the Difference?
Central and local IRBs share the same research oversight goals, but NIH’s single IRB mandate challenges local IRBs to adapt their broader responsibilities.
Virtual Symposium: Gene Therapy Research in the Age of COVID-19
Gene therapy research continues its rapid expansion in the clinical setting, especially in infectious disease, rare disease, and oncology. To support discussion of emerging genetic research issues, Advarra presents its first virtual symposium.
Keep in Touch: Tips for Working with a Single IRB for the First Time
Recent regulations and policies have ushered in the era of mandated single IRB (sIRB) review. Many institutions must now establish policies and processes for working with an external sIRB.
How Sites Can Prepare for COVID-19 Genetically Engineered Vaccine Studies
Currently the most prominent coronavirus vaccine candidates contain engineered genetic material. Sites wishing to participate in this research should be prepared for the additional requirements of research involving genetic engineering.
A Tale of Two Sites: The Power of Integrated Research Administration
Site timelines for studies can vary widely across the industry due to differences in internal efficiency. In this blog, James Riddle (Advarra VP of Institutional Services and Strategic Consulting) tells the tale of two sites, one with an integrated research administration, and one without.