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.
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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
How to Successfully Conduct Virtual Investigator Meetings
In a remote clinical research landscape, a successful virtual investigator meeting can ensure a more cost-effective and compliant clinical trial.
Cell & Gene Therapy vs Drug Research: What’s the Difference?
Cell and gene therapy’s popularity has grown exponentially in the past year. However, it’s important to understand how cell and gene therapy research is different from traditional drug development.
Addressing Barriers to DEI in Clinical Research
Breaking down barriers to participation in clinical research has long been a challenge, affecting every aspect of the industry. As
Making the Most of Site Training: Lessons from the Pandemic
The shift to virtual site training reveals innovative ways to maintain engagement and consistency, enhancing site readiness in remote settings.
The Power Of Patient Advocacy In Drug Development
Recently, we discussed the importance of connecting with advocacy groups in order to create more trial diversity. As a result
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
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug
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.
Building a Foundation for Regulatory Success in the Post-Pandemic Landscape
The past year has been one of the most challenging ever for those working in healthcare and clinical research. The
Study Startup Success for BioPharma and MedTech: Engage a Research Compliance Partner
A key element to successful study startup is identifying efficiencies to help meet critical milestones. Engaging with research compliance experts