Site Coordinators: An Untapped Resource

Throughout the entire clinical development, who has the most interaction with prospective and active subjects? Who is primarily responsible for the quality of the source data that ultimately decides the approvability of all biopharmaceutical products?

Principal investigators were asked who satisfaction surveys should focus on during a study. Site Coordinators were named more than half the time, ahead of PIs themselves.

Yes, the answers are identical: the site coordinator, study coordinator, or clinical research coordinator, whatever title you choose. These individuals are the keystone, the glue that holds the study process together. Without them very few patients would be randomized, informed consent forms would not be completed, site contracts would not be negotiated, data would not be entered, queries would not get resolved, and database lock would be delayed.

Delay is the key point. Site coordinators help a study stay on track. Without good ones, hitting milestones would be nearly impossible.

ISR dedicated an entire study (The Voice of the Site Coordinator— www.isrreports.com/reports) to understanding site coordinator's experiences and perspectives on improving the success of clinical trials.