Webinar
From Reactive to Proactive: How to Evolve Your Research Program During a Global Crisis
Many research programs are evaluating how to keep research moving forward in the face of critical staff shortages and budget limitations—during the COVID-19 pandemic and beyond. Sites are busier than ...
Institutional Perspectives: Leveraging Technology to Meet Operational Goals During COVID-19
The COVID-19 pandemic ushered in a myriad of changes for clinical research professionals. One of the most impactful has been the immediate shift to remote processes to accommodate both research ...
Fireside Chat: The Future of Clinical Trials and Site Engagement
The COVID-19 pandemic has proven that research can be done more efficiently. To make these efficiencies sustainable, the sites’ perspective must be considered. Sponsors, CROs, and sites should engage early ...
Virtual Symposium: Gene Therapy Research in the Age of COVID-19
Gene therapy research is expanding rapidly in the clinical setting, especially in oncology, rare diseases, and infectious diseases—in fact, gene therapy research plays a crucial role in responding to the ...
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 ...
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 ...
How to Engage Your IRB to Improve Clinical Trial Risk Management
We will discuss real-world examples of how IRBs can further improve risk management and quality systems through education of all aspects in clinical trials.
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.
Preparing for and Responding to an FDA Inspection
Ellen Liedel-Sargent and Robert Romanchuk outline key activities that can help prepare a research site for a positive inspection experience.
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