Understanding International Data Transfer’s Impact
The landscape of data privacy is certainly dynamic and, at times, imposing. In particular, transferring data across borders can be difficult to navigate.
Research Compliance
Data Integrity – It’s All About the Data!
In this increasingly digital world, we have to remember data is now available in many different medians, including paper. When we think of clinical trials and the critical data
6 Tips for Creating Effective Clinical Trial Training
Effective training for clinical trials requires clear, engaging content tailored to busy site staff. Focus on bite-sized learning, mobile optimization, and learner feedback.
IRB Review of Phase I Research: Balancing Ethics and Efficiency
Phase I research demands careful IRB oversight, balancing participant safety with timely reviews. Proactive strategies can help address its unique challenges.
Beginner’s Guide to Minimal Risk Research
When an institutional review board (IRB) determines research is “minimal risk” (as defined in Department of Health and Human Services
4 Key Integrations for Your Clinical Trial Management System
In this blog are some key CTMS integrations — using systems your institution has likely implemented — your team can use to streamline research operations.
IRB Review of Social Media Recruitment and Retention Programs
Social media can be a valuable tool for researchers to connect with and recruit potential clinical trial participants. However, US regulations
Why Institutions Should Consider an Externally Administered IBC
Clinical trials for gene therapy are booming, especially in the fields of oncology, infectious diseases, rare diseases, and regenerative medicine.
Beginner’s Guide to IND Safety Reporting Under 21 CFR 312(c)
Read about IND safety reporting required under FDA 21 CFR 312.32(c), challenges faced in adhering to the regulation, and strategies to ensure compliance.
Study Activation: Top Four Takeaways from Research Sites
While enrolling subjects is arguably the most crucial aspect of clinical research operations, this cannot be done without activating a
Q&A from Remote Monitoring: Study Compliance In A Changing World
In a recent webinar, Advarra experts Emily Eldh and Ben Shankle provided insights and information in Remote Monitoring: Study Compliance
Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance
To maintain Part 11 compliance, research sites must validate electronic systems storing FDA-regulated records, safeguarding data integrity and accuracy.