Reporting to the IRB: What NOT to Report
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.
Central Neurology Review Services
With extensive experience in neurology research and clinical care, Advarra’s Central Neurology Review (CNR) provides the robust human subject protections review that research institutions prefer.
Conducting Planned Emergency Research in the Era of sIRB
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…
Making Mobile Clinical Trials a Reality
New technologies and related methodologies could offer clinical research professionals expanded capacity for low-cost, efficient, and expansive collection of high-quality participant data—both within and beyond the clinical setting. The Clinical…
How to Engage Your IRB to Improve Clinical Trial Risk Management
IRBs are in a unique position to impact risk management in clinical research. Their role is designed to protect research participants, but this can also equate to elevating best practices…
Phase I Services
Advarra offers the most comprehensive approach to Phase I research with experience overseeing thousands of Phase I studies in the US and Canada.
CANCELLED – After the Compliance Date: Revised Common Rule FAQs
In this webinar, Michele Russell-Einhorn, JD, Advarra's CCO and IO, and Judith Carrithers, JD, Advarra's Director of Regulatory Affairs, discuss FAQs and common issues in implementing the revised Common Rule.
Making a List, Checking It Twice… The Revised Common Rule Is Coming to Town!
Judith Carrithers, JD, Director of Regulatory Services at Advarra, and Michele Russell-Einhorn, JD, Chief Compliance Officer and Institutional Official at Advarra, discuss a checklist of action items to consider and…
Oversight Challenges with Patient Centered Outcomes Research
Luke Gelinas, PhD, IRB Chair at Advarra, discusses some of the oversight challenges presented by PCOR and shares policy recommendations for managing such challenges.
IRB Services: Canadian Review
Advarra’s Canadian review service combines local, expert oversight with streamlined processes and the most extensive site reach in Canada to aid you in the conduct of efficient, responsible research.