Decentralized Clinical Trials Involving Biologics: Unique Challenges
Join this webinar to learn about FDA insights on DCTs and biologics. Dr. Eisenman discusses biosafety, risks, and key considerations for safe trials.
IRB
Preparing Your Action Plan for the FDA sIRB Mandate
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Budgeting for IRB Review: A Guide for HRPP Leadership
At institutional research programs around the U.S., there exists a pervasive myth: internal institutional review board (IRB) reviews are free.
Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research
Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The European Parliament recently adopted
Conducting Research With CAR T Cells
Conducting Research With CAR T Cells Regulatory and Practical Considerations Having proven successful in trials for blood cancers considered resistant
Single IRB Review: Tips for Sponsors and CROs Working with Institutional Sites
Discover strategies for sponsors and CROs to navigate single IRB mandates, from institutional IRB roles to optimizing compliance and efficiency.
Navigating Local Considerations When Developing sIRB Reliance Policies
Implementing an sIRB process requires addressing unique local considerations, from consent requirements to cultural nuances, ensuring a streamlined yet ethical review process.
Impact of sIRB Mandates on Study Teams
As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges while ensuring compliance and participant protection.
Interim Staffing: Reinvigorating Your Human Research Protections Program
Interim staffing offers HRPPs specialized expertise, fresh perspectives, and support for accreditation and structural improvements without disrupting daily operations.
Striking the Balance: Ethics, Inclusion, and Vulnerability in Research
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
In this blog, we’ll take a look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”
Navigating sIRB Complexities: An Interactive Session
Got questions about sIRBs? Join experts as they share insights and priorities, plus a Q&A to address common concerns and your live questions.