Research Compliance
Considerations for IRB Review: Artificial Intelligence & Machine Learning
Read this blog to learn IRB review considerations for artificial intelligence and machine learning studies.
The NDA 505(b)(1) Pathway to Regulatory Approval
Dive into current regulatory challenges your teams face and recommends strategies to expedite go-to-market plans across multiple activities
DMC vs EAC: What’s the Difference?
This blog outlines the requirements for each committee, what it does, and the critical roles each plays in keeping research participants safe.
Simple Ways to Uncover Research Compliance Blind Spots
This webinar offers three strategies to check and reduce blind spots regularly to improve compliance oversight.
Beginner’s Guide to Clinical Trial Billing Compliance
Ensuring proper compliance within clinical trials is confusing, so here are best practices to ensure charges and claims are correctly routed
Local Versus Central IRBs: What’s the Difference?
Local IRBs and central IRBs are not really that different, although sIRB mandates have complicated things for local IRBs.
Clinical Conductor Study Build
Learn how Advarra’s Clinical Conductor Study Build services expedites study activation, saves time, and increases protocol compliance.
Advarra’s Support for Institutions
Find out how we keep site centricity at the forefront through our technology, services, and extraordinary team members.
Planned Emergency Research and Exception from Informed Consent
This white paper outlines considerations for those involved in planning, designing, conducting or reviewing EFIC studies
Beginner’s Guide to Institutional Review Boards (IRBs)
In the U.S., there is an independent group overseeing clinical research, ensuring participants’ rights and welfare are protected.
What Level of Review Does Your Study Need?
In this infographic, we share useful information for investigators to know which level of IRB review likely applies to their study.
Keys to Advancing Your Biotech Go-to-Market Plan
Essential keys for growing biotech companies on navigating the complexities of the FDA 510K filing process.