Case Study: Clinical Trials Present Labeling Challenges

What’s so important about public health these days? Does the average citizen know that public health involves far more than just education and healthy living? Or do they think…”Don’t we know enough about medicine so we don’t have to worry about big epidemics like those centuries ago?”

The truth is―unfortunately―no! We really don’t know everything about the diseases out there today. Although, scientists are certainly making incredible advancements in the medical field, even as you read this article!

A well-established and esteemed resource for collecting and maintaining all types of clinical research data happens to be one of customers. The EMMES Corporation is a contract research organization that provides statistical and epidemiological expertise for clinical studies done through both the US Government and commercial areas such as pharmaceuticals.

Cryo VialsFor example, the Division of Microbiology and Infectious Disease (DMID) under the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) sponsors biomedical and health-related research as well as extramural studies to control and prevent diseases caused by infectious agents (except HIV) in people of all ages and risk categories. DMID contracts with EMMES to serve as the Statistical and Data Coordinating Center (SDCC) for their Clinical Research in Infectious Diseases (CRID) project. This project involves over 100 vaccine and infectious disease protocols of both domestic and international study sites in Phase 1-4 clinical trials of bacterial, viral, and parasitic vaccines, therapeutics, and other biologics and drugs.

The Problem

Recent pandemic flu studies conducted under the CRID Contract were crucial in the development of H1N1 pandemic flu vaccines. So, where does EIM come into play? With our labels, of course! You see, EMMES needs to track thousands of specimens…from thousands of clinical trial subjects…at dozens of study sites for laboratory testing. Their labels have to be resistant to extreme temperatures, particularly in freeze/thaw regimens and long-term storage. They also need to age without loss of print quality or adhesive bonding and not deteriorate in any way that might compromise their specimens. The sizes of the labels are important as well, since they needed to fit on specific specimen tubes.

The Solution 

Our durable white and clear CryoLabel® materials proved to be the perfect fit for EMMES. The CryoLabel® we provide them comes in various formats—roll-form, fanfold, partially or completely printed in duplicate sets of two or three labels with text, barcodes and even different color-coded stripes. Our customized labels fit their test tubes, withstand repeated freeze/thaw cycles, hold up to various chemicals and still maintain legibility. The labels also offer the necessary strength to stay securely fixed to specimens even after repeated handling.

Once more, EIM is proud to offer reliable, durable labeling solutions for such impressive and critical clinical studies.

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