Blog

In the U.S., there is an independent group overseeing clinical research, ensuring participants’ rights and welfare are protected.

Understand current regulatory trends in clinical research and how it will shape the industry moving forward.

Essential keys for growing biotech companies on navigating the complexities of the FDA 510K filing process.

A clinical trial management system (CTMS) can bring powerful efficiencies, insights, and compliance to sites' day-to-day operations.

Take a closer look at what significant risk and nonsignificant risk determinations mean for medical device clinical trials.

Learn how to start ensuring the membership and leadership of your NCI-designated cancer center reflect the population you serve.

Find out how the Food, Drug, and Cosmetic Act defines cosmetics and how a test article can be subject to multiple FDA regulatory frameworks.

Learn what CBPR is, how it's employed, the benefits of conducting it, & how to best approach this type of research.

The Bring Your Own Technology philosophy will produce synchronization between sites & sponsors, which improves both care & clinical outcomes.

Most training programs are outdated, unengaging, & redundant. Learn how to make a program achieving both regulatory requirements & your goals

In this blog, we share tips and best practices for writing an impactful clinical audit report.

By utilizing a vendor that offers both IRB and IBC services in-house, sponsors can streamline reviews and enhance study startup timelines.