Ask Advarra Live: The Real-World Impact of COVID-19 on Research
The unprecedented COVID-19 pandemic has quickly changed how we live and work. This extraordinary situation has resulted in a significant impact on IRB-approved protocols and research yet to go through…
Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
Luke Gelinas, IRB Chairperson at Advarra, proposes a practical framework for evaluating offers of payment and applies it to case studies to yield guidance on challenging ethical and regulatory issues…
Reefer Sanity: IRB Review That Won’t Vaporize Cannabis Protocols
Cannabis and cannabis-derived products are being used with increasing frequency in both recreational and therapeutic settings. With more widespread use of cannabis, how can data from well-designed clinical research trials…
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.
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.…