IBC
Sponsors: Are Your Sites Ready for an FDA Inspection?
Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.
mRNA Cancer Vaccines and Therapies: An Overview
Learn about mRNA’s potential impact on cancer research, the technology’s unique challenges, and strategies for researchers developing mRNA-based cancer studies.
Trend Report: DE&I in Clinical Research: Where we are Today
How is the research community addressing recent regulatory actions urging improved diversity and representation in clinical trials?
How Gene Therapy Will Move Rare Disease Research at Warp Speed
There is great potential for research surrounding rare diseases. Uncover various types of gene delivery and its impact on diverse populations in the U.S.
Leading CRO Accelerates Startup with Integrated, Centralized IRB/IBC Reviews
Advarra’s integrated central IRB and IBC review services helped Parexel accelerate the delivery of life-saving and innovative gene therapies.
Thinking About the Box: Considerations for Transport of Investigational Products
Ensure safe transport of investigational products with meticulous planning and rigorous procedures to mitigate hazards and uphold biosafety.
Clinical Trial Startup: Insights from the Industry
Clinical research professionals provide relevant insights into challenges and barriers impeding study start up.
Public Perceptions of Clinical Trials: A Comprehensive Survey
In a complex and competitive climate, we sought the understand existing perceptions surrounding clinical research trials.
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.
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.
4 Unique Challenges of Oncology Trials
Oncology research is unique in many ways, including the challenges researchers face in conducting cutting-edge trials.