Advarra
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
What do the regulations say about unanticipated device effects and IRB reporting? In this blog, Advarra addresses unique requirements for medical device studies.
Reporting to the IRB: Investigator Noncompliance
Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.
Your Guide to sIRB Mandates
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.
Protocol Feasibility to Promote Trial Efficiency
Many studies do not accrue subjects at the site level, which contributes to a significant amount of waste of staff time and monetary resources. Read more:
Study Activation: A Complex Process That Doesn’t Have to Be Painful
If the clinical development time of a new treatment is to ever decrease, reducing the time in study activation is necessary so actual research can be done.
How Research Informs the COVID-19 Response
Research doesn’t just inform medical treatment; it informs public health and public policy, and it helps explain human behaviors. Read more:
IRB Review of Coronavirus and Other Emerging Infectious Disease Research: Issues to Consider
Advarra IRB experts discuss unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review. Read more:
Are “Virtual Trials” Mainstream Yet?
Advarra VP of Insitutional Services James Riddle discusses using virtual trial components in traditional study designs. Read more:
Key Biosafety Considerations for Coronavirus Research
Advarra Director of Biosafety Daniel Eisenman reviews opportunities, risks, and risk mitigation strategies for coronavirus research. Read more:
Revised Common Rule Compliance Now in Full Effect—and What That Means
The Revised Common Rule is here after multiple delays, exceptions, and many training sessions. As of January 20, 2020, this regulation is in full effect.
Beyond the Regulations: More Considerations for Emergency Research
Go beyond the regulatory requirements and examine three key actions research organizations must consider before conducting planned emergency research.
Most Popular Blogs of 2019
What did the research community enjoy most in 2019? Read Advarra's most popular blogs from industry experts and IRB members here.