Columbia University Irving Medical Center – Ensuring Integrity in Clinical Trials

Company Overview

Columbia University Irving Medical Center’s pharmacy division is responsible for dispensing medications used in clinical trials, requiring strict temperature monitoring to maintain research integrity and regulatory compliance. Clinical trials depend on the reliability of investigational drugs, and any temperature deviations can compromise drug efficacy, invalidate trial results, and ultimately hinder advancements in medical research.

Given the scale and significance of clinical research conducted at Columbia, ensuring 

constant oversight of storage conditions is not just a priority—it is an absolute necessity. Even slight temperature fluctuations in investigational drug storage can affect a study’s validity, leading to delays, financial losses, or potential harm to patients.

Challenges

Before adopting EoScene AssureTemp™, the pharmacy relied on manual temperature monitoring, which introduced several critical issues:

• Delayed awareness of temperature excursions: Staff would only learn about temperature deviations when they returned on-site the next business day, leaving investigational drugs at risk overnight or over weekends.
• Potential medication compromise: Without real-time alerts, medications could be unknowingly exposed to unsafe temperatures, jeopardizing their integrity and impacting trial participation.
• Compliance vulnerabilities: Regulatory agencies require documented proof of temperature stability, and manual logging increased the risk of missing data points or inaccurate records.

With clinical research organizations demanding higher standards of precision, Columbia needed a modern, automated solution to protect its investigational products and maintain regulatory adherence.

EoScene’s Solution

When the respondent joined Columbia University Irving Medical Center in 2019, EoScene AssureTemp™ was already integrated into the pharmacy’s workflow. Its continued use was driven by three key factors:

• A user-friendly interface that made it easy for all staff to use and navigate.
• Prompt technical and account support ensuring seamless troubleshooting and issue resolution.
• Comprehensive remote monitoring and alerting that empowered staff to react in real time, even when off-site.

Key features of EoScene AssureTemp™ included:

• Automated alerts for temperature deviations, allowing pharmacy staff to immediately intervene and prevent medication loss.
• Cloud-based, real-time monitoring, enabling remote oversight without requiring staff to be on-site at all times.
• Seamless data logging and reporting, simplifying compliance documentation and reducing administrative burdens.

Results & Impact

The implementation of EoScene AssureTemp™ resulted in:

• Greater peace of mind for pharmacy staff, knowing investigational drugs were being monitored 24/7.
• A reduction in manual temperature logging, saving time and reducing the risk of documentation errors.
• Enhanced compliance confidence, ensuring adherence to trial requirements without unnecessary labor.

A particularly impactful experience occurred when a refrigeration unit malfunctioned during summer. Instead of staff remaining on-site overnight, one individual was able to remotely monitor temperature stability, ensuring intervention only when necessary—a significant improvement in operational efficiency and staff well-being.

Columbia University Irving Medical Center rated both customer support and system reliability 10/10, reflecting complete confidence in EoScene AssureTemp™ as a vital tool in clinical trial management.

‍