As cell and gene therapies (CGT) advance into the clinical stage, many cold chain complexities arise not only for these novel products but also for the biological samples that must be collected from patients during clinical trials. Managing these sensitive materials—including storage, transportation, and tracking—requires robust and adaptable systems to ensure safety, integrity, and regulatory […]
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Informed consent is a legal and ethical requirement of all clinical research. While specific patient consent guidelines differ around the world1, all conform to the Declaration of Helsinki’s principles of protecting patients involved in clinical research2. Using broad, generic or tiered consent will allow researchers to reuse patient samples in future studies. Many funding agencies, such as […]
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Clinical trials take years. In some cases—a decade or more. The need for shorter clinical study timelines from the bench to the bedside is critical because it means patients get access to new treatments faster. Besides the enormous amount of time involved, this level of research requires funding. Upwards of hundreds of millions of dollars […]
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Academic biobanks support preclinical and translational research by collecting, storing, analyzing, and distributing biological samples and associated data to academic and industry researchers. And in fact, hundreds of academic biobanks have been established over the past decade to support the growing emphasis on personalized medicine, genetic and genomic research, biomarker identification, and companion diagnostic development.1 […]
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As the demand for biospecimens continues to increase, biorepositories must develop strategies to optimize utility, efficiency, and scope of their biosample collections. Modern technology solutions must not only address sample tracking and annotation but also enable sample sharing wherever possible. How can this be implemented? Biorepositories and Biobanks Modernized Research Strategies Once upon a time, […]
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Clinical samples are important. Samples collected at a doctor’s office or hospital are used to diagnose disease, guide treatment, and predict patient outcomes. They’re also important for drug discovery and development, where they can be used to track disease stages, look for biomarkers, develop diagnostic assays, and many other purposes. Knowing how to deal with […]
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Patient recruitment is one of the biggest challenges when running a clinical trial. Repurposing samples for multiple research studies can help reduce the burden of patient recruitment and the burden on patients themselves. Repurposing Samples as a Clinical Study Strategy World Pharma Today recently published an article by Katheryn Shea, Global Biobanking Lead at Azenta Life […]
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Modern biomedical research relies on a large variety of high quality biospecimens, annotated with precise and detailed metadata. Consequently, biorepositories must secure, and convey to their customers, excellence in all of their operations. Enter two biobanking accreditation and certification programs that include external review. Ensuring High-Quality Data from Biobanked Samples Garbage in, garbage out. In all scientific research, this is […]
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