On Friday June 12th, 2015 YPrime, a leader in clinical software products and services, entered into a partnership with Berlinger USA, LLC, a global producer of temperature monitoring systems. This new partnership brings together two of the most critical parts of the clinical supply chain to allow fast, simple access to stability data. Berlinger's popular Q-tag® and Fridge-tag® USB enabled temperature monitors are easily adapted for use with YPrime Interactive Response Technology (IRT) system to automatically approve, reject, or quarantine materials based on the product stability profile.
"Clinical supply chain professionals have been telling us that managing temperature excursions is taking too much time out of their work day." says Shawn Blackburn, CEO at YPrime. He goes on to include that, "...co-clinical teams are getting their work done in spite of, rather than because of the software." YPrime plans to change that trend by streamlining the workflow at clinical sites and disclosing the data to those who need it.
Berlinger USA, LLC President, Patrick McGrath adds, "This is a great opportunity to share valuable data across an entire study and even program in a way that has never been possible before." Berlinger's devices will be utilized during clinical trial shipments from the depot as well as for storage at the clinical site to collect cumulative temperature data.
Bryan Clayton, YPrime Director of Product Strategy and Innovation explains the process. "Acceptable temperature ranges will be entered into the system at the start of a trial by clinical supply users. From there, pharmacists or other clinical site personnel will simply plug the Q-tag® into their computer's USB port to automatically upload the actual time and temperature data from the temperature monitor." Previous implementations of temperature monitoring in IRT systems have required manual entry that was both error prone and time consuming. "This new offering will streamline the process of ensuring compliance and improve operational efficiency and quality control with timely access to temperature logs, integrated reports and timely alerts. This will really eliminate all of the problems that we saw previously..." adds Clayton.
Recent trends in clinical trial design coupled with developments in regulations have made temperature monitoring a common practice in most studies. Some sources in the field have cited an increase in temperature monitoring spend at more than five times higher than the cost just three years ago. Monitoring data cumulatively at the clinical site has also become more and more challenging for teams. "The Fridge-tag® was built specifically to address in-clinic data collection," adds McGrath.
"Making data transparent and available has always been a priority of ours," says Blackburn, "...when we found a company like Berlinger, that shares that approach, we knew we had the opportunity do something big."
Clinical teams who use YPrime IRT will be able to take advantage of this new technology and integration immediately. Other plans are in the works to allow third party IRT providers access to the system as a stand-alone solution.