Research Compliance
Medical Devices: “Significant Risk” Versus “Nonsignificant Risk” Determinations
Take a closer look at what significant risk and nonsignificant risk determinations mean for medical device clinical trials.
eSource Study Build Services
Advarra’s eSource Study Build Services delivers high quality study builds and forms in Advarra eSource utilizing best practices in data capture and form design
Ensuring Success with Clinical Development Planning
This white paper describes how to ensure a clinical plan’s feasibility, focusing on issues that matter, and mitigates anticipated program risk.
Executing a Successful Clinical Strategy
A clinical development plan is designed to bring an investigational medicinal product to market through outlining risks and opportunities to a program.
Research Involving Cosmetics: What you Need to Know
Find out how the Food, Drug, and Cosmetic Act defines cosmetics and how a test article can be subject to multiple FDA regulatory frameworks.
It’s Time for Sites to “Bring Your Own Technology” (BYOT)
The Bring Your Own Technology philosophy will produce synchronization between sites & sponsors, which improves both care & clinical outcomes.
Advarra Professional Services for Clinical Research
View how Advarra’s Professional Services integrating with corresponding technology solutions can increase your research productivity.
Advarra Research-Ready Training Services
Advarra’s Research-Ready Training applies effective and innovative eLearning techniques for required research topics.
Reporting to the IRB: What Does and Does Not Need to be Reported
This white paper outlines IRB reporting requirements, why reporting is important, and what should and should not be reported.
Critical Steps for Writing an Impactful Clinical Audit Report
In this blog, we share tips and best practices for writing an impactful clinical audit report.
Driving Site Efficiency and Visibility Using a CTMS
As clinical trials grow more complex, this eBook reviews how a CTMS may help your organization address challenges as you conduct research.
IRB Review of International Research
Advarra’s institutional review board (IRB) can support local ethics committee reviews and confirm compliance with U.S. regulations.
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