Research Compliance
Operationalizing Research Analytics: Today, Tomorrow, Someday
Uncover how analytics, artificial intelligence, and machine learning are reshaping the foundational elements of clinical research.
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.
A Phased Approach to QMS
A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post 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.
Clinical Trial Startup: Insights from the Industry
Clinical research professionals provide relevant insights into challenges and barriers impeding study start up.
Unlocking Study Activation: 2023 Study Activation Report
Access the survey report now for current perspectives on study startup activities impacted by rapidly evolving technology and tools.
What Happens When a Study Fails to Meet Its Recruitment Targets?
Explore IRB considerations for overcoming study enrollment barriers while ensuring risks to participants are appropriately minimized.
Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance
A robust corrective and preventive action (CAPA) stands as a critical tool for proactively addressing deviations in clinical research.