CRO
Keys to Advancing Your Biotech Go-to-Market Plan
Essential keys for growing biotech companies on navigating the complexities of the FDA 510K filing process.
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.
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.
Beginner’s Guide to Community-Based Participatory Research
Learn what CBPR is, how it's employed, the benefits of conducting it, & how to best approach this type of research.
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.
The Advantages of Outsourcing IRB and IBC Reviews to One Partner
By utilizing a vendor that offers both IRB and IBC services in-house, sponsors can streamline reviews and enhance study startup timelines.
Understanding Various Decentralized Terms in Research
Virtual, remote, hybrid, decentralized, mHealth, telehealth: Find out what these terms mean for clinical research.
GDPR Implementation Support
Learn how Advarra’s global consulting expertise enabled iSpecimen to implement GDPR with no service interruption to their customers.
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