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Making the decision to outsource your preclinical histopathology to a contract laboratory can deliver a myriad of benefits including: the assurance of regulatory compliance; timely and reliable results; and, perhaps most importantly, access to the most highly trained and experienced staff without the cost of hiring and training those individuals in-house. Veterinary pathologists play a key role as team members contributing to drug discovery and safety. To ensure that the veterinary pathologist evaluating your study has the proper qualifications, be sure to ask the following questions:

Successful preclinical research programs rely on board-certified veterinary pathologists to provide critical and accurate analyses pertaining to safety and clinical relevance of the experimental product. To obtain the most comprehensive and high-quality final reports, it is vital to ensure that the study pathologist has access to the most effective support team and most pertinent tools available. Below is a list of items that will provide crucial support to the study pathologist and will ensure the highest quality pathology report:

Market demand for outsourced preclinical research services is growing. Pharmaceutical and biotech companies need contract research organization (CRO) partners who can help them maximize productivity and efficiency in research and development. Faced with a variety of cost pressures, such as patent expiries and more competition from generics, pharmaceutical companies are building strategic relationships with CROs at an increasing rate.

If you’re running a preclinical study that requires histopathology services, you’ll soon discover (if you haven’t already) that high quality histotechnicians play a vital role in making sure your study stays on track. They are responsible for the process of preparing tissues for microscopic examination by a pathologist, who then issues a report on the findings. When high quality slides are delivered to the study pathologist for evaluation, reports can be issued in a timely manner and your study continues to stay on time and on budget.

The objective of the necropsy is to examine the animal macroscopically, identifying any lesions that may help the pathologist diagnose what may have been taking place within the body before the time of death. The prosector will dissect the tissues from the animal and place them in fixative for histology. Once slides have been prepared, the study pathologist evaluates the slides and explains clinical and laboratory findings that may have been found in specific organs. Use of careful and attentive necropsy techniques will yield the most accurate interpretation of results and will ensure that clinically relevant observations are not overlooked.

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!