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By Peter Caulfield
DaVita Clinical Research (DCR), a Minneapolis, MN-based research center, has purchased and is using 13 Veriteq validatable data loggers to monitor temperature in two -70°C freezers, one -80°C freezer, two -20°C freezers, and four refrigerators. According to DCR laboratory manager Denise Cosgrove, the automated Veriteq system has greatly improved the accuracy, reliability, and quality of their monitoring, a function that was previously performed manually.
DCR's freezers contain blood, urine, dialysis and pharmacokinetic samples used by DCR in pharmaceutical clinical trials that DCR conducts on human subjects on behalf of pharmaceutical company sponsors. The company stores between 2,000 and 4,000 samples in their -70°C and-80°C laboratory freezers. The samples need to be kept at constant low temperatures in order to maintain their stability and in order to satisfy validation requirements of the U.S. Food and Drug Administration (FDA) and by the sponsors of the clinical trials. This requirement is especially crucial if the samples need to remain frozen for a long time during lengthy trials.
Cosgrove says the Veriteq loggers are "three thousand times better than the way we used to do it," which was to open the freezers and check the interior temperatures manually. "Just the act of opening the freezers changed the temperatures a few degrees," Cosgrove says. "Veriteq loggers are much more accurate and they virtually eliminate the possibility of human error."
Cosgrove is enthusiastic about Veriteq loggers because they perform a function that is critical to DCR's credibility as a research center: They provide validatable 21 CFR Part 11-compliant temperature records that DCR can show to the FDA and the pharmaceutical companies that sponsor the trials.
The Veriteq logging system employs both electronic records and signed paper records. Once the electronic records have been created, they cannot be modified. This means they can be printed and signed with full assurance that they are a true and accurate representation of the data that's been recorded and collected.
DCR guides pharmaceutical advancements from initial human trials all the way through FDA approval. It conducts Phase I-IV clinical trials of drugs and devices for pharmaceutical companies using subjects with diabetes, chronic heart failure and chronic kidney failure. DCR has conducted over 320 clinical trials over the last 16 years and has worked with over 65 drug and device sponsors. As of early July 2003, DCR was supervising 17 active clinical trials.
Cosgrove began DCR's program to update its lab facilities and processes in 2002, after several years with the American Red Cross. "I am using my experience and training from the Red Cross to update DCR's lab processes," Cosgrove says. "We clearly needed to move up to more user-friendly equipment."
Furthermore, Cosgrove says, DCR wanted to upgrade the quality and availability of validatable documentation to show the FDA and DCR's pharmaceutical sponsors. "We wanted to improve the consistency and detail of our information."
After conducting a thorough search, DCR purchased the following Veriteq data loggers in March 2003 and installed them shortly afterwards:
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