Newsletter | March 7, 2023

03.07.23 -- A New Solution For Multisite Research

FDA’s September 2022 NPRMs: What They Mean For Academia And Industry

The Food and Drug Administration released two Notices of Proposed Rulemaking on September 28, 2022, proposing harmonization with the Health and Human Services 2018 Common Rule (also referred to as the revised Common Rule). Get highlights on the major proposed changes and learn how they could impact clinical research.

A Tool Kit For Sponsors And CROs: Shifting Institutional Sites To Central IRB

Are you leveraging centralized IRB review for better study efficiency? Convert more sites to use your study’s central IRB with these proven insights and tips for navigating the central IRB reliance conversation.

Single IRB Review For Multicenter Research: A Guide For Institutions

Several initiatives in the United States have made it clear that federal agencies favor centralized review by a single IRB for multicenter research. Learn about what institutions should consider as the research community continues to evolve toward mandated centralized IRB oversight.

sIRB Oversight For Multisite Research

Looking to improve organizational efficiency and maintain compliance? Discover how clinical teams using a single institutional review board — meaning one IRB of record overseeing all clinical trial sites participating in a multisite study — can eliminate patchwork systems and reduce administrative burdens of managing multiple IRBs’ requirements and turnaround times.

Tips For Working With A Single IRB For The First Time

A new era of mandated single institutional review board review has been ushered in by recent regulations and policies. Learn how to protect research participants, properly address local requirements, and coordinate a competitive and productive research program with a single IRB.

IRB Services For Institutional Sites

Advarra can serve as your partner for everything from single investigational sites to multisite research consortia and therapeutic networks.

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