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IRB Review of Changes to Previously Approved Research
Make sure you know the IRB review requirements for amendments involving changes to IRB-approved protocols and other study modifications.
Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance
Monitor four critical metrics across your sites to prevent persistent challenges to clinical trials
mRNA Cancer Vaccines and Therapies: An Overview
Learn about mRNA’s potential impact on cancer research, the technology’s unique challenges, and strategies for researchers developing mRNA-based cancer studies.
Trend Report: DE&I in Clinical Research: Where we are Today
How is the research community addressing recent regulatory actions urging improved diversity and representation in clinical trials?
How Sponsors and Sites Work Together to Improve Protocol Compliance
As trials continue to increase in complexities, sites and sponsors must work together to minimize deviations and cause for FDA findings.
Turbocharging Clinical Trial Activation Timelines
Understanding roadblocks to study activation and what your organization can do to mitigate them can ease study startup burdens.
Making Good Clinical Practice More Understandable
This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.
Unpacking The Role of a Right-Sized QMS in Study Startup
Discover the crucial role of a customized QMS in streamlining and optimizing study startup processes.
GxP Compliance in Clinical Research
This white paper walks through key GxP principles and regulatory requirements and gives a real-world case study.
Leading CRO Accelerates Startup with Integrated, Centralized IRB/IBC Reviews
Advarra’s integrated central IRB and IBC review services helped Parexel accelerate the delivery of life-saving and innovative gene therapies.
Thinking About the Box: Considerations for Transport of Investigational Products
Ensure safe transport of investigational products with meticulous planning and rigorous procedures to mitigate hazards and uphold biosafety.
Global, Comprehensive Audit Support
Discover how a pharmaceutical company partnered with Advarra Consulting to establish a regulatory framework.
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