Integrated research compliance solutions to streamline your study
Advarra® provides institutional review board (IRB), institutional biosafety committee (IBC) and GxP/HRP research compliance consulting services with unprecedented clarity.
Trust Advarra’s integrated solutions and collaborative approach to make your research altogether better.
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The Association of Clinical Research Professionals (ACRP) has appointed Sergio Armani, Advarra VP of Business Development, to its Board of...
Planned emergency research (subject to the 21 CFR 50.24 regulations) is challenging for IRBs to review under any circumstance. Now, in the era of single IRB (sIRB), add in the…
Despite clarification from FDA and OHRP, many of the "potential" unanticipated event reports IRBs receive are either submitted unnecessarily or don't pertain to the aspects of research the IRB oversees.
We often get questions about exactly what events should be reported to the IRB. We understand that “reportable events” can be tricky: some “events” are specifically referenced in the regulations,…