Sponsor’s Guide to IRB Approval (Part IV): Preparing IRB Documents That Prevent Delays
A strong protocol and well-drafted consent form are essential, but they are not enough on their own to support a
IRB
Federal Public Policy Briefing: Understanding 21 CFR 50.54: When FDA-Regulated Pediatric Research Requires Federal Review
Federal Public Policy Briefing: Understanding 21 CFR 50.54: When FDA-Regulated Pediatric Research Requires Federal Review Research involving children that poses
Does mRNA Require IBC Review? How the NIH Guidelines Apply to Clinical Trials
Let me start with a question I get more and more frequently from research sites as mRNA continues to expand
Sponsor’s Guide to IRB Approval (Part III): Building an IRB-Ready Informed Consent
Sponsor’s Guide to IRB Approval (Part III): Building an IRB-Ready Informed Consent For sponsors, informed consent is one of the
Sponsor’s Guide to IRB Approval (Part II): How to Draft a Clinical Trial Protocol That Stands Up to IRB Scrutiny
A strong clinical trial protocol does more than describe how a study will run. It also helps reviewers understand why
Sponsor’s Guide to IRB Approval: What Every Sponsor Needs to Know Before Submitting a Study
Introducing the “‘Sponsor’s Guide to IRB Approval’“ Institutional review board (IRB) approval protects the rights, safety, and welfare of research participants, and
New Paper Makes the Case for AI-Specific Guidance in Research Oversight
AI is becoming a routine part of how research proposals are prepared and reviewed, from drafting applications to supporting administrative
Reducing Startup Delays in Oncology Clinical Trials Through Consistent IRB Processes
Traditional clinical trial designs often delay progress due to rigid protocols and frequent amendments. Adaptive and platform trial models introduce flexibility and shared infrastructure, reducing startup delays, cutting costs, and enabling sponsors to conduct faster, more efficient research.
Q&A with Advarra’s Client Experience Partner Brian Boggs
As a member of Advarra’s client experience team, Brian Boggs plays a pivotal role in helping research clients navigate complex
Q&A with Advarra’s Associate Director of Client Services Anna Carnevale
Over the past 14 years, Anna Carnevale, associate director of client services at Advarra, has seen her team grow from
Q&A with Advarra’s new Senior Vice President, FDA Regulatory Advisor, Jan Hewett
Clinical research drives medical progress. Advarra ensures participant safety and ethical standards through expert IRB oversight for life-changing therapies.
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.