The IND Journey Phase I – Navigating Success
Explore strategies for advancing investigational new drug (IND) submissions and a comprehensive guide through Phase I of the IND journey.
GDPR Implementation Support
Learn how Advarra’s global consulting expertise enabled iSpecimen to implement GDPR with no service interruption to their customers.
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Submitting an IND application for the first time? Consider three common CMC pitfalls that may impact submission.
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:
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:
Meeting the Challenges of Investigator-Initiated Trials
How does investigator-initiated research differ from other types of clinical research? Advarra IRB Chairperson Robert Romanchuk explains.
The Challenge of Unproven Regenerative Stem Cell Therapies
Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.
Six Key GDPR Questions to Review
Questions still remain about GDPR and its applications. Have you considered these six key questions to ask within your organization?
Can Ethics Review Catch Up to the CBD Craze?
CBD, a non-psychoactive cannabinoid, is experiencing a massive surge in popularity, but clinical research lags behind in verifying effective uses.