Improving Study Activation Time for Gene Therapy Research
This blog explores how research sites are focusing on their institutional biosafety committee (IBC) programs as part of overall study activation time.
IBC
IBC vs. IRB: What’s the Difference?
Gene therapy research requires both IRB and IBC oversight—while IRBs protect participants, IBCs ensure community and environmental safety with local site-specific reviews.
Data Safety Monitoring Boards Facilitate Ethical Research
In clinical trials, the safety of research participants is paramount. An organization conducting or sponsoring clinical research can ensure participant
Navigating Key Complexities in the Development of Cell and Gene Therapies
Discover how biotech organizations navigate the unique challenges of cell and gene therapies, from regulatory shifts to recruitment and market uncertainty.
Risk Assessment for use of Engineered Genetic Materials in Clinical Research
The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may
Rare and Orphan Diseases in Regulated Development
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Regulatory Trends in Cell and Gene Therapies
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.
Safe Sharps Handling When Dispensing Investigational Products
Institutional biosafety committees (IBCs) frequently receive questions about the proper methodology for preparing a syringe for transport from a drug
Advarra Trend Report: Current State of Trial Opportunity and Selection
Discover survey findings on trial selection, from cumbersome feasibility questionnaires to improving transparency and site opportunities.
Clean Bench vs Biosafety Cabinet: What’s the Difference?
Institutional biosafety committees (IBCs) frequently receive questions about the proper type of hood for use with biological materials and the
Top Barriers to Participation in Clinical Trials
Recruiting study participants is one of the most challenging tasks in the clinical trial process, and arguably one of the