Other Resources
Study sponsors typically spend 20% or more of a study budget on site monitoring. Despite that huge cost, even experienced site monitors typically find only about half of the important issues. There must be a better way...and there is: A mature quality management system (QMS) at the site can build quality in rather than relying on site monitors to inspect errors out. The FDA has been promoting risk-based site monitoring for a decade, and this is the logical next step. To learn more, click here.
12 Questions we need to answer to achieve diversity in clinical research
We can minimize duplicative efforts and accelerate learning through collaboration. The best place to start this collaboration is to develop consensus answers to 12 fundamental questions. To start with, how do we define "diversity"? To view an article in ACT Magazine that discusses these questions, click here.
What does diversity in a clinical trial actually mean?
A recent article in ACT Magazine includes a spreadsheet you can use to define, prioritize, calculate and communicate a quantitative diversity score for your clinical study. Now we can know exactly what diversity means. To view the article, "Calculating Diversity in Clinical Research Studies," click here.
For a free download of the clinical study diversity calculator, please enter the following information:
Free-for-all competitive enrollment may be fast, but it can create chaos. Managed competitive enrollment avoids chaos, is more predictable, is no slower, and may deliver superior quality. To view an article on managed competitive enrollment, click here.
Has a study sponsor ever notified its sites that obsolete study records may be destroyed? Apparently not, and that’s why study sites are storing countless boxes of obsolete study records. What a pointless waste. To view an article that addresses this problem, click here. To view additional material, click here.
To download a Site Council flyer, click here.
