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Is your research organization harnessing the transformational power of digital pathology? Ongoing developments in the application of virtual microscopy and digital pathology systems are transforming research on a global scale. Advances in pathology image management and analysis are creating new avenues for discovery, collaboration, and efficiency in preclinical research. If cost or logistics are hindering your organization's entry into the digital arena, take advantage of technological innovations by building a digital pathology partnership with a proven histology and pathology services provider.

Conclusions drawn from analysis of preclinical histology provide the cornerstone for planning future studies and clinical decision-making down the line. Whether utilizing classic stains and dyes or more specialized immunological and molecular techniques, it is of utmost importance that the histotechnologist provide quality, consistent results. Reliable, high-quality slides allow for the most accurate assessment of pathologically relevant changes in the tissue.

A quality preclinical pathology report will include critical analysis and interpretation of histopathological and toxicological data, providing the foundation for making a decision on how best to proceed with your preclinical research. Prior to study initiation, it is crucial to ensure that the study pathologist is up to the task of delivering an accurate and comprehensive pathology report. Although, often incorporated as an appendix to the final study report, the pathology report should constitute a stand-alone document that is ultimately responsible for characterizing the preclinical safety of your compound or biologic.

You have an anxious sponsor waiting for their pathology report or prepared microscope slides. Workloads are high and you don’t have the staff to get the work done on time and on budget. What do you do? Outsource!

Contract Research Organizations, biorepositories, and researchers globally store billions of specimens such as tissues, plasma, urine and other fluids for future use. In order to preserve the integrity of these samples, they must be collected and stored under optimal conditions. While storing biospecimens at −20°C has been a common practice, samples for long-term storage are increasingly being kept in ultralow temperatures ranging from −70°C and −80°C to prevent sample degradation.

Your GLP study materials are irreplaceable, as they contain all the information about what procedures were done, how they were performed, when the work was completed, and who performed the task. Without data, nothing else really matters. That’s why it’s critical that you ensure your study materials are stored safely and in compliance with Good Laboratory Practices (GLPs). All study materials, data and specimens, must be retained and easily retrievable after study completion. GLPs state “There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens.”

You want to outsource the histology portion of your preclinical study, so you must ensure the project remains GLP compliant. Good Laboratory Practices (GLPs) guide how “laboratories plan, perform, monitor, document and archive study activities in an effort to enhance the quality and validity of test data.” Preclinical research studies generating data for submission to the Food and Drug Administration (FDA) must adhere to these guidelines no matter where the study is conducted or who performs the work. This means that contract laboratories, like the one you may outsource your study to, are also subject to FDA surveillance audits.

The doorbell rings and waiting at the front door are FDA inspectors... What do you do? First, welcome them in. Second... DON’T PANIC! Unless directed “For Cause”, FDA visits are routine inspections used to assess your lab’s compliance with applicable regulations and to verify the quality and integrity of your study data.

After a highly successful expo last month at the Society of Toxicology, HSRL is pleased to be attending the 32nd SQA Annual Meeting and Quality College in Grapevine, Texas on April 3-8, 2016. HSRL’s Quality Assurance Unit is a key component to our success. HSRL’s QAU audits 100% of our histopathology data, performs facility inspections annually, and ensures all of our services adhere to HSRL SOPs as well as GLPs.