Fully integrated solution: Turn a 25-day manual temperature-monitoring data evaluation into instant decision making
"Over the last several years, the cold chain logistics market for clinical trials has shown a growth of about 10%. This is largely related to the increasing number of biologicals and monoclonal antibodies that are under study. Therefore, cold chain failure in clinical trials has an increasing impact," says Dr. Harald van Weeren, Segment Manager Clinical Trials at Berlinger.
Our organizations understand the risks of managing temperature-controlled IMP, and therefore, we focused on designing a solution to help reduce risk and eliminate the core issues. Such problems include limited transparency and missing information, the lack of immediate centralized visibility, time-consuming excursion management and slow decision making, time-consuming data consolidation for audits, wastage of drugs, and patient rescheduling or lost.
Through this partnership, endpoint and Berlinger can provide Sponsors with a fully integrated solution, taking a 25-day manual temperature-monitoring data evaluation and turning it into instant decision making. This drastically reduces costs up to 7-digit figures and improves patient safety, allowing for fast decision-making through complete visibility of the temperature history.
Sponsors and sites will reap immediate benefits through this sophisticated technology integration in a variety of areas:
- Education: Less instruction needed for the site users
- Handling: A reduction in admin time, manual handling, and associated risks
- Excursion Management: Reduce the risk for dispensing drugs affected by a temperature deviation
- Patient: Reduce failed patient visits and increase patient safety
- Audit: All of the temperature data available in one system for easy preparation
- Drugs: Reduce waste of trial products
"Patient safety has always been a high priority for endpoint. As cold chain logistics become increasingly important due to the ever-growing number of studies that work with biologics, we understand how vital it is to maintain the chain of custody. This ensures that IMP does not go outside of agreed temperature ranges for that product. We are happy to be partnering with Berlinger on an integration providing a seamless solution for both the sponsor and site," says Jeff Rubesin, Senior Director, Product Strategy at endpoint Clinical.
endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. For the past decade, their customer-obsessed team of professionals has been continuously evolving their suite of technologies to help Sponsors achieve clinical trial success. Their dynamic IRT solution, PULSE®, for patient randomization and management, site management, and drug supply management and leading-edge clinical supplies management tool, DRIVE, has proven to maximize the supply chain and minimize operational costs, and ensure timely and accurate patient dosing. endpoint is headquartered in San Francisco, California, with offices across the US, EU, and Asia. www.endpointclinical.com