Beginner’s Guide to Institutional Review Boards (IRBs)
In clinical research, institutional review boards (IRBs) a vital role in ensuring participant rights and ethical standards are upheld throughout the trial.
sponsors
Keys to Advancing Your Biotech Go-to-Market Plan
For nearly 10 years, a growing biotech company worked to develop a nitric oxide and delivery device for babies in
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
Research Involving Cosmetics: What you Need to Know
The Food and Drug Administration (FDA) is a U.S. public health authority within the Department of Health and Human Services
Beginner’s Guide to Community-Based Participatory Research
With diversity, equity, and inclusion efforts currently at the forefront of the research community’s collective mind, we’re also seeing increased
It’s Time for Sites to “Bring Your Own Technology” (BYOT)
Sites gain control with Advarra’s BYOT approach, eliminating redundant tasks and fostering efficient collaboration between research stakeholders and participants.
Critical Steps for Writing an Impactful Clinical Audit Report
The amount of detail required in an audit may vary – ranging from an executive, high-level summary with detailed observations,
The Advantages of Outsourcing IRB and IBC Reviews to One Partner
Gene therapy studies are a relatively recent addition to the world of clinical research. As a result, the unique requirements
Understanding Various Decentralized Terms in Research
As many research organizations are becoming more patient-centric and adapting to technological advancements and remote requirements, they are re-designing the
Navigating the FDA Emergency Use Filing Process
In an effort to create safe, effective, and affordable ventilators to help combat the foreseeable shortages due to COVID-19, one
Improving Patient Centricity and Research Access
A clinical research trial can only be as strong its participant population, but it’s challenging to find eligible patients.
For FDA Inspection Readiness, Accountability is Key
Dawn Wydner, former Food and Drug Administration (FDA) Consumer Safety Officer, LCDR, and current Managing Expert for Advarra’s Quality Center