General Perceptions of Clinical Trials in 2023
Significant growth and adoption of new research approaches in the life sciences industry has driven an increasingly complex and competitive […]
Biotech Organization Partners with Advarra to Become Inspection Ready
An established biotech organization sought out a partner to provide investigator site audits, trial master file (TMF) audits, for-cause audits, and other quality assurance services. Turning to Advarra, they developed a partnership through Advarra’s proven GxP services and successful U.S. Food and Drug Administration (FDA) guidance. Download the case study to learn more
FDA/OHRP Harmonization and Your HRPP Operations
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Using the Portfolio Rationalization Model to Implement and Optimize Your Training Program
This eBook outlines how your organization can implement the portfolio rationalization model (PRM) to effectively evaluate your training program.
4 Modernized Functions Every Sponsor Needs for Study Startup
Efficient study startup relies on modern tools, including standardized documentation and real-time dashboards, to minimize delays and control costs.
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.
Privacy and Confidentiality in the Age of Mobile Apps and Connected Devices
Find out what researchers should consider in selecting and using these technologies and how to adequately inform participants of the potential risks.
Full Board vs Expedited vs Exempt: Why IRBs do That
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Data on the go: Mobile Application Considerations for Clinical Trials and Beyond
Explore regulatory and ethical considerations for mobile apps in clinical trials, from device regulations to consent language and IRB reviews.
University of Nebraska Medical Center Streamlines Regulatory Management and Accelerates Study Startup with Advarra eReg
Learn how the University of Nebraska Medical Center improved efficiency, remote workflows, and study startup with Advarra eReg integrations.
Unique First-in-Human Phase I IRB Considerations you Might not Know About
Explore unique IRB considerations for first-in-human Phase I trials, from informed consent to participant protections and robust incentives.
Is Your Site Ready for an FDA Inspection?
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.