Blog

Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.

What do the regulations say about unanticipated device effects and IRB reporting? In this blog, Advarra addresses unique requirements for medical device studies.

Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.

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.

Review a list of considerations for site-sponsor tasks to streamline startup, reduce redundancy, and refine technology choices for effective partnerships.

As technology evolves and the industry streamlines research workflows, implementing SSO can lead to significant improvements in both user experience and security.

Make sure you know the IRB review requirements for amendments involving changes to IRB-approved protocols and other study modifications.

Monitor four critical metrics across your sites to prevent persistent challenges to clinical trials

Learn how to optimize clinical trial initiation with centralized processes, intuitive intake forms, and custom reporting and streamline workflows for efficiency.

Learn about mRNA’s potential impact on cancer research, the technology’s unique challenges, and strategies for researchers developing mRNA-based cancer studies.

Explore the transformative power of eSource in clinical research, streamlining data collection for efficiency and cost savings.

As trials continue to increase in complexities, sites and sponsors must work together to minimize deviations and cause for FDA findings.