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.
Advarra meets the growing needs of oncology by offering robust human subject protections that cancer research institutions expect.
Join the Gene Therapy Network to accelerate study activation, gain IBC support, and position your site as a preferred choice for sponsors.
Advarra’s biosafety experts streamline startup for gene therapy trials with comprehensive IBC reviews and proven rapid turnaround times.
Comprehensive IBC submissions require detailed materials, including investigator CVs, safety protocols, and site-specific SOPs for study agent handling.
Antibiotic resistance is an emerging problem. Some have argued bacteria are developing antibiotic resistance faster than we can research, develop,
Advarra’s IBC services offer rapid, flexible solutions for IBC review, especially critical for gene therapy and other high-stakes research.
Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all
Join this webinar to learn about FDA insights on DCTs and biologics. Dr. Eisenman discusses biosafety, risks, and key considerations for safe trials.
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Conducting Research With CAR T Cells Regulatory and Practical Considerations Having proven successful in trials for blood cancers considered resistant
Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their
