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Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval
As FDA CBER prepares to launch Operation Warp Speed for Rare Diseases, there is an expected rapid growth in gene therapy.
How Centralized IBC Review Can Benefit Gene Therapy Research
Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.
Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs
Discover strategies for proactively assessing compliance for an FDA Inspection Readiness visit. Address deficiencies and implement corrective actions.
Unlocking Global Potential: Partnering Across Varying Sites in Study Startup
Join us as Advarra experts outline how sponsor organizations can work with various site types across trials and adapt their resources accordingly.
Device Risk Determinations for IVD Research
Learn the FDA's investigational device exemption requirements for clinical trials involving investigational in vitro diagnostic devices.
Reporting Unexpected Incidents to the IBC
Find out which unexpected events you should report to the IBC during a clinical trial, and what to expect from the IBC's review.
Phases of Clinical Research: A Detailed Overview
Gain a comprehensive understanding of the various phases involved in clinical research, their objectives, and outcomes that ensure safe and effective clinical treatment.
Ace Your Next FDA Inspection
Discover valuable insights and expert guidance on navigating FDA inspections in clinical research.
Biotech Organization Partners with Advarra to Become Inspection Ready
A biotech organization becomes inspection ready through Advarra's GxP services and successful U.S. Food and Drug Administration guidance.
4 Unique Challenges of Oncology Trials
Oncology research is unique in many ways, including the challenges researchers face in conducting cutting-edge trials.
IBC vs. IRB: What’s the Difference?
Gene therapy research is full of promise, but because of the risks, it’s a highly regulated space requiring oversight by an institutional biosafety committee (IBC).
Data Safety Monitoring Boards Facilitate Ethical Research
Data safety monitoring boards (DSMBs) ensure research participants are protected and results are valid. Learn about DSMB composition, concerns, charter, and challenges.
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