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…
Preparing for Multisite Gene Therapy Studies
The fast and dramatic growth in the field of gene therapy is unprecedented, as the US FDA and regulatory agencies of several other countries have begun issuing approvals for licensed…
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…
Real-World Evidence:
What Researchers Must Know
Experts Rebecca Miksad and Tim Stoddard of Flatiron Health provide a practical look at the role of real-world evidence (RWE) in regulatory, drug development, and clinical decision-making.
Is GDPR a Four Letter Word?
Demystifying the EU Data Privacy Law and Its Impact on Research
In this webinar, Aarthi B. Iyer, Managing Director & Senior Regulatory Attorney at Kinetiq, and David C Babaian, Senior Consultant & Senior Regulatory Attorney at Kinetiq, discuss the regulatory impact…
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.
Preparing for and Responding to an FDA Inspection
Robert Romanchuk, IRB Chair at Advarra, and Ellen Liedel-Sargent, Senior Director of Consulting at Advarra, outline key activities that can help prepare a research site for a positive inspection experience.…
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.