Key Biosafety Considerations for Coronavirus Research
The recent outbreak of the novel 2019 coronavirus in Wuhan, Hubei Province, China, has...
FEATURED E-BOOK
Making Good Clinical Practice More Understandable
This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.
Revised Common Rule Compliance Now in Full Effect—and What That Means
After multiple delays, exceptions, and oh-so-many training sessions, on January 20, 2020, we reached...
Beyond the Regulations: More Considerations for Emergency Research
In this blog post we go beyond the regulatory requirements and examine three other...
Most Popular Blogs of 2019
As we near the end of 2019, let's take a look back at the...
Reporting to the IRB: What NOT to Report
Despite clarification from FDA and OHRP, many of the "potential" unanticipated event reports IRBs...
Making Sense of the New HUD Guidance
For almost a decade, the FDA guidance on humanitarian use devices (HUDs) dated July...
Should Social Media Be Part of Your Research Toolbox?
Social media holds tremendous promise in the research sphere but requires sensitivity to pertinent...
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...
Advarra Acquires Forte:
What You Need to Know
On September 5, 2019, Advarra announced its intent to acquire Forte. The combined organization...
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