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New FDA Certificate of Confidentiality Guidance: What Does it Mean for You?
Certificates of Confidentiality protect participant privacy by preventing disclosed sensitive information during research.
Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
FDA is placing an increased emphasis on compliance with 21 CFR Part 11. Institutions, health systems, IRB offices, private research clinics, and developers—to name a few—need to understand the basics of the regulation and how to comply.
Institutional Responsibilities Under a Federalwide Assurance (FWA)
When institutions are engaged in non-exempt human subjects research supported or conducted by a Common Rule department or agency, they are required to provide written assurance that they will abide the requirements of the Common Rule.
Q&A – Racial Diversity in Clinical Trials: Building Trust in Participant Engagement
Our experts answered some of the most popular questions from "Racial Diversity in Clinical Trials: Building Trust in Participant Engagement."
Takeaways From the FDA’s VRBPAC Meeting – October 22, 2020
On October 22, 2020, the FDA's VRBPAC met to discuss the development, authorization, and licensure of vaccines to prevent COVID-19.
By the Numbers: Our Response to COVID-19
See the data points in our infograhpic to find out how Advarra helps keep research moving forward.
How Medicare’s New Imaging Program Affects Clinical Trials in Oncology
Billing compliance is an essential part of clinical trial participation, and this is especially important for high-cost services such as CT scans, PET scans, nuclear medicine, and MRIs. However, organizations ...
Beginner’s Guide to Investigator-Initiated Trials
In investigator-initiated trials, an investigator takes on the clinical study as both the sponsor and investigator. Learn more about IITs impact on the clinical research industry.
5 Tips for Successful Project Management in Clinical Research
Learn how to improve project management practices at your clinical research organization and reduce the risk of complications on clinical trials.
Is GDPR Coming to the US? CCPA and Its Impact on Research
New California regulations apply to companies who have information about CA residents regardless of where the company is located. Read more:
Research Staffing Strategies During Challenging Times
With hiring freezes, furloughs, in-person restrictions, and changes in workflows and documentation, the COVID-19 pandemic has had a significant effect on clinical research staffing. What will it look like when ...
Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements
Find out more about what to report to whom--and when--in the Q&A blog follow-up to our recent webinar. Read the answers to popular audience questions:
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