How Single IRB Review Mandates Help Research Sponsors
The Food and Drug Administration’s (FDA’s) proposed single institutional review board (sIRB) mandates are...
FEATURED E-BOOK
Making Good Clinical Practice More Understandable
This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from...
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene...
eReg Benefits for Clinical Research: Use Cases for all Types of Sites
While regulatory management takes time and effort, using an eRegulatory system can help staff...
How Single IRB Works in Practice: Challenges and Efficiencies
The single institutional review board (sIRB) model is gaining popularity due to NIH and...
Sickle Cell Disease: The Importance of Amplifying Patient Voices
Having a one in four chance of developing sickle cell disease (SCD) is uniquely,...
NIH 2023 Data Management and Sharing Policy: What you Need to Know
In an effort to accelerate the sharing of biomedical research results, the National Institutes...
Honoring Clinical Trailblazers: 2023 Video Series
This February, Advarra’s “Honoring Clinical Trailblazers” video series paid tribute to the outstanding achievements...
Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials
How do you know your experimental therapy is working? Sometimes, it can be as...
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