Blog
Planning for Complex Change at Your Organization
Navigate the ever-changing landscape of innovation and technology in clinical operations by discovering strategies to help your organization.
Interim Staffing: Reinvigorating Your Human Research Protections Program
Uphold research compliance best practices with an innovative approach to HRPP.
The Value of Continuity: Program-level Data Safety Monitoring Boards
Using a single Data Safety Monitoring Board for an entire therapeutic program ensures continuity and offers cost savings and efficiency gains.
Understanding FDA’s 2024 Draft Guidance on DMCs
Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
What do the regulations say about unanticipated device effects and IRB reporting? In this blog, Advarra addresses unique requirements for medical device studies.
Reporting to the IRB: Investigator Noncompliance
Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.
SAE Reporting and the IRB: Adverse Events in Drug Studies
Explore the basics of SAE reporting to the IRB for drug studies. Learn about reportable events, FDA regulations and guidelines, and how to assess AEs.
Checklist to Reduce Burden on Sites and Patients
Review a list of considerations for site-sponsor tasks to streamline startup, reduce redundancy, and refine technology choices for effective partnerships.
Enhancing User Experience, Security, and Compliance with Single Sign-on
As technology evolves and the industry streamlines research workflows, implementing SSO can lead to significant improvements in both user experience and security.
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
Optimizing Site Initiation Timelines Through Centralized Processes
Learn how to optimize clinical trial initiation with centralized processes, intuitive intake forms, and custom reporting and streamline workflows for efficiency.