Medical Devices: “Significant Risk” Versus “Nonsignificant Risk” Determinations
In medical device research, the determination of “significant risk” or “nonsignificant risk” is sometimes confusing, especially for those new to
In medical device research, the determination of “significant risk” or “nonsignificant risk” is sometimes confusing, especially for those new to
The Food and Drug Administration (FDA) is a U.S. public health authority within the Department of Health and Human Services
With diversity, equity, and inclusion efforts currently at the forefront of the research community’s collective mind, we’re also seeing increased
Learn the essentials of IRB reporting, including why it matters, what’s required, what’s not, and tips to avoid common reporting challenges.
Gene therapy studies are a relatively recent addition to the world of clinical research. As a result, the unique requirements
As many research organizations are becoming more patient-centric and adapting to technological advancements and remote requirements, they are re-designing the
About the Advarra In Conversations With… The future of healthcare innovation hinges on research and clinical trials. Advarra sits down
The year 2021 brought many advancements in the clinical research industry. We’ve pushed for more diversity and inclusion in clinical
Historically, decentralized clinical trials (DCTs) were heralded as the future of patient-centered research. But how can your organization “walk the
Transcript Institutions, universities, academic medical centers, hospitals, and healthcare systems all play a critical role in clinical research. In the
As the COVID-19 pandemic has forced a shift toward remote modalities, mobile health (mHealth) technologies have been on the rise.
When SARS-CoV-2 (the virus causing the disease COVID-19) broke out in 2020, the clinical research community needed to pivot quickly