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?
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.
—Industry Standard Research
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.