Blog

Reporting to the IRB: Unanticipated Device Effects (UADEs) in Medical Device Studies

October 2, 2019

In this blog, we’ll take a look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray…

Blog

How Centralized IBC Review Can Benefit Gene Therapy Research

September 18, 2019

Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements here.

Blog

Advarra Acquires Forte:
What You Need to Know

September 5, 2019

On September 5, 2019, Advarra announced its intent to acquire Forte. The combined organization leverages mutual strengths in supporting the research community with client service, regulatory expertise, and technology-enabled efficiencies…

Blog

Compensating Clinical Trial Participants: The Basics

August 28, 2019

Many clinical trial protocols include plans to compensate participants for their contribution to the research. According to FDA’s information sheet...

Blog

What Is a Screening Consent?

August 14, 2019

Informed consent is an ongoing process to ensure the participant has an initial and ongoing understanding of the research and its risks. In this blog, we’ll take a look at…

Blog

Quality Improvement Project vs Human Subject Research: What’s the Difference?

July 24, 2019

When does a quality improvement program cross over into research? How do the two categories inform one another in the context of human subjects protection? Advarra IRB Executive Chair Sarah…

Blog

The Future of Phase I Oncology Studies

July 10, 2019

Phase I studies in oncology pose challenges unlike any other early phase study. Most phase I studies begin with healthy volunteers, but because of the unique nature of the trial…

Blog

The Noble Pursuit of Investigator-Initiated Research

June 19, 2019

Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.

Blog

The Challenge of Unproven Regenerative Stem Cell Therapies

June 5, 2019

Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.

Blog

Six Key GDPR Questions to Review

May 1, 2019

Questions still remain about GDPR and its applications. Have you considered these six key questions to ask within your organization?