Safety Precautions for Laboratory Research With COVID-19 Specimens
The current global pandemic has brought biosafety to the spotlight. Biosafety practices must be customized to the proposed research as well as the existing facility and local regulatory requirements.
Trial Design in the Time of COVID-19: Complex and Efficient
Complex trial designs can eliminate less-promising investigational treatments quickly to speed development, but they remain under-utilized. The current pandemic offers a chance to consider strategies for facilitating adoption of such…
Clinical Trials Day: Thanking the Unsung Heroes
On Clinical Trials Day, now more than ever, it’s important to recognize and thank those unsung heroes at the focal point of research: research sites and institutions.
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…
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.
Q&A – Ask Advarra Live: The Real-World Impact of COVID-19 on Research
Experts from Advarra and Johns Hopkins University School of Medicine provided practical guidance on the COVID-19 research impact in a recent webinar. We’ve addressed the most popular Q&A topics here.
Differentiating “Public” and “Private” Internet Spaces in IRB Review
What is the difference between “public” and “private” internet spaces? This question has gained importance with the growing practice of using internet and social media platforms as a source of…
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.
Q&A Part 1 – Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
In a recent webinar, Dr. Luke Gelinas, IRB Chair at Advarra, provided a framework for evaluating offers of payment to research participants. In addition to outlining the challenging ethical and…
Protocol Feasibility to Promote Trial Efficiency
Scientific abstracts and articles have reported that 20-50% of studies do not accrue subjects at the site level (1-6). This contributes to a significant amount of waste in clinical research,…