Change Is Inevitable: Flexible IRT Systems And Effective Product Consultants Are Keys To Coping With Change

By Jon Paras, Vice President of Strategic Solutions, YPrime and Ryan Ridge, Senior Portfolio Director of IRT, YPrime

There are three certainties in life – death, taxes, and clinical protocol amendments. All joking aside, if anyone has conducted or been part of a clinical trial that was completed with no protocol amendments, that would be the exception to the norm. Generally, professionals who support clinical trial research operate under the expectation that a clinical protocol will be amended, and the only question is how many times it will be amended.

A common question we hear from those who are newer to clinical research is, “Why don’t sponsors take the time to get the protocol right the first time?” Experience has shown there are several factors, and we will tackle two of them in this article.