Research Compliance
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 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.
GDPR Implementation Support
Learn how Advarra’s global consulting expertise enabled iSpecimen to implement GDPR with no service interruption to their customers.
Budgeting and Billing Compliance in Study Activation
Faced with expanding their budgets, sponsors and sites must enable budgeting and billing compliance best practices starting at study activation.
Navigating the FDA Emergency Use Filing Process
Partnering with Advarra, one nonprofit successfully obtained an Emergency Use Authorization from the FDA within five weeks.
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