Optimizing Central Monitoring with Pfizer’s Crupa Kurien and Linda Sullivan
Centralized monitoring clinical trial programs can catch outlying data points in almost real time and quickly notify the clinical trial study team. That’s one of the key takeaways from Crupa Kurien’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium. Kurien is the central monitoring manager in the RBQM program at Pfizer, who currently manages and provides oversight for the company’s COVID-19 portfolio. For the most part, Kurien says, Pfizer’s central monitors disseminate data analysis internally. In addition, she notes, it is important that the signals from the central monitoring platform or dashboard are fine-tuned and broadly understand to a wide audience to make optimal use of the data analytics. Pfizer’s central monitoring program runs two basic types of analyses: key-risk indicator analysis and data quality assessment, Kurien says. Central monitoring specialists ae excellent critical thinkers, she notes, trained to question best practices and communicate effectively with other team members and corporate staffers. The pandemic accelerated the deployment of central monitoring at Pfizer, she notes, ensuring that any risks were mitigated in as close to real time as possible. Effective central monitors specialist listen to study teams, understand their protocols and work very quickly to prioritize any flagging issues.