Research Compliance
Vendor Qualification vs Requalification Audits: What’s the Difference?
Audits to support your vendor qualification and management program should be conducted using a risk-based approach. Read more:
The Opioid Crisis in America
Combating the opioid crisis requires urgent, evidence-based approaches that address clinical, research, and education issues. Read more:
Making a Case for Interim HRPP Staffing
Don't wait to fill an HRPP position until it's too late. Understand the risks of an understaffed HRPP and how interim staffing support can help. Read more:
Good Manufacturing Practices (cGMP): When Do They Apply?
When do current Good Manufacturing Practices (cGMP) regulations apply? Read more for FDA expectations for the application of cGMP to investigational drugs:
Human Research Protection Program Services
Download our info sheet to learn how Advarra can revitalize your human research protection program (HRPP) with customized consulting support
Q&A – The New Normal: Considerations for Restarting Research
Experts answer some of the most popular audience questions from the recent webinar The New Normal: Considerations for Restart Research. Read more:
Patient Engagement and the IRB
With increased efforts to engage and include patient and participant communities more closely in research, when does an IRB review become required?
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. Read more:
Keep in Touch: Tips for Working with a Single IRB for the First Time
Recent regulations and policies have many institutions establishing policies and processes for working with an external sIRB. Read more:
Q&A – Ask Advarra Live: The Real-World Impact of COVID-19 on Research
We have addressed the most popular Q&A topics from our recent webinar on the research impact of COVID-19 in this blog post. Read more:
Differentiating “Public” and “Private” Internet Spaces in IRB Review
The difference between “public” and “private” internet spaces has gained importance with the growing research use of internet and social media platforms as data sources. Read more:
Q&A Part 1 – Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
Dr. Gelinas answers audience questions we weren’t able to address during the webinar.
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