IBC

Ensure safe transport of investigational products with meticulous planning and rigorous procedures to mitigate hazards and uphold biosafety.

Clinical research professionals provide relevant insights into challenges and barriers impeding study start up.

In a complex and competitive climate, we sought the understand existing perceptions surrounding clinical research trials.

As FDA CBER prepares to launch Operation Warp Speed for Rare Diseases, there is an expected rapid growth in gene therapy.

Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.

Find out which unexpected events you should report to the IBC during a clinical trial, and what to expect from the IBC's review.

Oncology research is unique in many ways, including the challenges researchers face in conducting cutting-edge trials.

With the growing popularity of gene therapy research and genetically engineered vaccines, sites need to understand study activation impacts

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 (DSMBs) ensure research participants are protected and results are valid. Learn about DSMB composition, concerns, charter, and challenges.