CAR T Manufacturing and Toxicity
CAR T Manufacturing and Toxicity Pre-Clinical Considerations Genetically engineered therapeutics present diverse, and sometimes heightened, risks compared to traditional small
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Sponsors: Are Your Sites Ready for an FDA Inspection?
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
How Genetic Engineering Will Move Rare Disease Research at Warp Speed
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
mRNA Cancer Vaccines and Therapies: An Overview
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While
Trend Report: DE&I in Clinical Research: Where we are Today
Explore the state of DE&I in clinical research with survey insights on diversity plans, budgeting efforts, and progress in trial representation.
Leading CRO Accelerates Startup with Integrated, Centralized IRB/IBC Reviews
Discover how Parexel accelerated mRNA study startups with Advarra’s integrated IRB and IBC reviews, achieving rapid timelines and budget goals.
Thinking About the Box: Considerations for Transport of Investigational Products
Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. This critical task requires
Clinical Trial Startup: Insights from the Industry
The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology,
Public Perceptions of Clinical Trials: A Comprehensive Survey
The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight
Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval
Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for
How Centralized IBC Review Can Benefit Gene Therapy Research
Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements here.
Reporting Unexpected Incidents to the IBC
When unexpected events occur during the conduct of a clinical trial, research personnel may wonder if the event is reportable,