Brady identification products team up with Axiope software to develop a complex labeling, barcoding, and data cataloging system for an international influenza study.
The South East Asian Influenza Clinical Research Network (SEAICRN) is an international, multidisciplinary collaborative partnership funded through Oxford Univ., UK, by The National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), Bethesda, Md. SEAICRN is conducting an international study of an influenza treatment that may hold promise for the treatment of both severe and avian influenza in adults and children. Brady Corp., Milwaukee, Wisc., a company that specializes in identification products, teamed up with Axiope, Edinburgh, Scotland, a leading provider of data management solutions for laboratories, to develop a sample labeling, barcoding, and tracking system that would allow the research team to coordinate data between eleven hospitals and seven labs working with hundreds of study participants across four countries.
SEAICRN, which aims to perform Good Clinical Practice (GCP) clinical studies on influenza, is a partnership of 11 hospitals in Bangkok, Ho Chi Minh City, Hanoi, Jakarta, and Bethesda, and the Univ. of Oxford, NIH, Wellcome Trust, city, state, and the World Health Organization (WHO). SEAICRN contracted with Brady and Axiope to develop the extensive sample labeling and data management system required for their work.
Brady and Axiope first came together at a scientific conference several years ago. Axiope is the company that developed the Catalyzer software platform, the first comprehensive solution for laboratory data management, including inventory management and sample tracking, image management, and electronic lab notebook applications. Axiope identified Brady as the largest supplier of labels, labeling software, printers, and barcoding technology to the biomedical market. Both companies realized that each offered important components in the full spectrum of inventory data management.
According to Nigel Goddard, director of business development at Axiope, “There wasn’t the demand for cataloging software until a couple of years ago. But now, the time has come. Being able to put barcodes on things isn’t enough—you can’t manage it without a cataloging system.”
The labeling and data tracking system for the SEAICRN study was developed and put into use within six months—an incredible accomplishment for a project of this scope. In November 2006, the SEAICRN agreed to work with both Brady and Axiope to create the labeling and sample tracking system they needed for the study. Working together, the two companies had labels and software ready for the researchers’ first participant screening in April 2007, including 90 sets of pre-printed labels for each of the 11 sample collection sites.
Developing a successful system
 |
The size, complex design, and far-flung locations of the study presented particular sample labeling and cataloging challenges. The seven participating labs include one in the U.S., two in Thailand, three in Vietnam, and one in Indonesia, each using multiple clinics to screen thousands of individuals to find 600 participants who fit the study’s parameters and who would agree to participate in the study process.
Dean Sherwood, IT and database manager for the SEAICRN and the Mahidol-Oxford Tropical Medicine Research Unit (MORU) at Oxford Univ., ensures that the researchers have all of the technical and datacomm support they need to enter and retrieve study information from all points in the system. He points out that even those participants who fail to pass the screening process must have their samples cataloged and stored.
“We may need to go back to those samples at some point in the future—even though those participants weren’t enrolled, the samples may be relevant to the study endpoints,” Sherwood says.
Once participants are selected, each individual could potentially provide seven different samples on each of multiple visits to the clinic. Each of those samples, in turn, will be divided in up to three aliquots for the purposes of the study.
Goddard emphasizes collaboration as key to the development of a successful system. “Often end users have not thought through every aspect of the physical workflow. We go over it with them in excruciating detail—what they want to do, what the scientists need to do.” This process can include information such as where and how labels are scanned, when samples are checked in, and even the physical configuration of the labels.
“Because of the complexity with multiple labs and the urgent timeline, it was a very interactive process with the researchers,” Goddard explains. “We had to understand the problem well enough to design the database—we customized the software for the study.”
Brady and the SEAICRN communicated extensively to develop a customized FreezerBondz label to match both the specimens’ container sizes and the study’s workflow. Brady’s team combined the study’s particular needs with their expertise in label printing to create a unique label set containing 64 labels that could accommodate the number of participant visits, samples taken, and aliquots created. This label set, in turn, was used by Axiope to help develop the barcode configuration that would work the best for the information required and the labeling and scanning process used.
Label information includes sample type, date and time of collection, participant information, and storage location. This last category can present a particular challenge, since researchers need to know which row and column, in which box, in which freezer, and at which site each and every sample is stored. The 2-D barcode on the Brady labels ties into Axiope’s Catalyzer software to accommodate the addition of this information.
The collaboration proved to be a success for the research support team. “Because of the due diligence between the researchers and Axiope, the implementation of the software was straightforward. As the original project did not include SEAICRN printing barcode labels, Brady had pre-printed all the labels we needed to get the study going,” says Sherwood. “The teamwork of SEAICRN, Axiope, and Brady allowed for a smooth, successful implementation of the production system.”
Evolving with the users’ needs
Some adjustments have been made since the beginning of the study, to accommodate new or changing needs of the research team. Sample shipping is one example. “Early on we identified being able to ship samples from one lab to another as a need,” Goddard explains. “Subsequently, the labs wanted to be able to say ‘this whole box of samples has been shipped’ and have the system automatically deliver an update for all of the samples in the box.”
The complete integrated system includes the customized Axiope Catalyzer software, customized Brady FreezerBondz labels, BradySoft labeling software (integrated to work with the Axiope software to populate the label format and create the 2-D barcode), Brady CR3 Barcode Scanners, and Brady 300 MVP Plus printers. A Md.-based Brady distributor preprinted the 50,000 – 60,000 label sets needed to get the study started. Labels are now printed at the research labs and sent to the participating hospitals.
The study is expected to span the next three or four years and will help researchers determine the effectiveness of a promising influenza treatment. Given the number of influenza deaths annually, and the risk of more virulent, treatment-resistant strains of the virus gaining prominence in the global landscape, the research—and the labeling and data systems that make the research possible—could have enormous benefits for the health of millions worldwide.
Resources:
• Axiope, Edinburgh, Scotland, 866-279-8367,
www.axiope.com
• Brady Corp., Milwaukee, Wisc., 888-272-3946,
www.bradyid.com
Published in R & D magazine: Vol. 50, No. 1, February, 2008, p.18.
