COVID-19 Lessons Learned: Technology and Agility in the New Clinical Trial Landscape
Clinical trials research was forced to evolve and embrace technology in the wake of the COVID-19 pandemic. This unprecedented crisis created a necessary disruption in the use of technology to…
The New Normal: Considerations for Restarting Research
Throughout the COVID-19 pandemic, we have continually heard what the “new normal” could mean for our work lives, social lives, schools, communities, and our medical system. But what does it…
sIRB 101: An Introduction to Relying on an External IRB
Federal mandates for single IRB (sIRB) review of multisite research have ushered in a new era of sIRB oversight. Multisite research funded by NIH, HHS, and other agencies must now…
How Sites and Sponsors are Collaborating to Move eSource Forward
In this webinar, Shannon Roznoski, Director of Product Management at Advarra-Forte and Michael Buckley, Manager, CRIT Enterprise Innovation at Memorial Sloan Kettering Cancer Center will discuss their experience as members…
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…