The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.
Antibiotic resistance is an emerging problem. Some have argued bacteria are developing antibiotic resistance faster than we can research, develop,
Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their
A centralized CTMS team streamlines trial initiation by uniting resources, ensuring data accuracy, and reducing bottlenecks for efficient site startup.
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While
A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study.
Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. This critical task requires
Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for
Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements here.
Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device
When unexpected events occur during the conduct of a clinical trial, research personnel may wonder if the event is reportable,
This blog explores how research sites are focusing on their institutional biosafety committee (IBC) programs as part of overall study activation time.
