Biosafety
Bacteriophage Therapy: A Promising Solution to Antibiotic Resistance
Get to know about one possible solution to antibiotic resistance: bacteriophages: viruses that infect bacteria.
Decentralized Clinical Trials Involving Biologics: Unique Challenges
Find out what FDA says about decentralized clinical trials and biologics, and what this means in practice.
Conducting Research With CAR T Cells
This white paper is a guide for research professionals looking to conduct CAR T cell studies for the first time, as well as for those seeking to expand their existing portfolio.
The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering
A formal hazard communication or IBC SOP is critical to ensure clinical personnel understand the risks involved with genetically engineered investigational products.
CAR T Manufacturing and Toxicity
Find out what FDA guidance says about integrating gene delivery vectors, such as CAR T cells, and gene editing technologies (like CRISPR).
Sponsors: Are Your Sites Ready for an FDA Inspection?
Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.
Optimizing Site Initiation Timelines Through Centralized Processes
Learn how to optimize clinical trial initiation with centralized processes, intuitive intake forms, and custom reporting and streamline workflows for efficiency.
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.
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.
A Phased Approach to QMS
A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study.
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.
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