Research Compliance
Let’s Get Ethical
Advarra's IRB Chairs Luke Gelinas and Amanda Higley discuss hot topics in clinical research, including cannabis studies and data ownership.
A Look at the Processes Behind Clinical Endpoint and Event Adjudication
Take a closer look at how and why we leverage proprietary, custom, and intelligent technology in our EAC program
Top-Tier University Stays Compliant with Advarra’s HRPP Assessment
A top -tier university worked with Advarra’s Institutional Research Center of Excellence to assess HRPP compliance with federal regulations
Why Device, Diagnostic, and Digital Therapeutic Research Needs Endpoint Adjudication
This blog outlines when a device clinical trial sponsor should engage an EAC or CEC to provide specific medical expertise & safety oversight.
Understanding the EU Clinical Trials Regulations Updates
The new European Union regulations have significant implications for sponsors submitting trials in the EU.
Improving Regulatory Workflows in Study Startup
This newsletter outlines the Consortium's efforts to improve regulatory workflows in study startups.
Addressing Research Technology Challenges to Gain Sponsor Buy-in
Encouraging site-owned technology platforms enables site staff to produce their best work, increasing the likelihood of a study’s success.
The Rise of the Clinical Research Network: Using Technology to Connect Sites and Sponsors
An integrated approach to the clinical research industry’s technology landscape can improve access and diversity, save time, and better serve patients
IRB Services for Federal Grants
View this info sheet to learn about Advarra’s IRB expert oversight and guidance to support your next federal grant proposal.
Considerations for IRB Review: Artificial Intelligence & Machine Learning
Read this blog to learn IRB review considerations for artificial intelligence and machine learning studies.
The NDA 505(b)(1) Pathway to Regulatory Approval
Dive into current regulatory challenges your teams face and recommends strategies to expedite go-to-market plans across multiple activities
DMC vs EAC: What’s the Difference?
This blog outlines the requirements for each committee, what it does, and the critical roles each plays in keeping research participants safe.
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