News & Events

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.

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.

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.

Managing histology services internally can require a great deal of time and capital expenditure. Outsourcing services such as these continues to increase as clinical and nonclinical laboratories strive to maximize their resources, increase their productivity and expand their capabilities without adding to their workforce. Here we cover 4 major benefits of outsourcing your histology services.

We all know histology services do not come cheap. But, did you know you could be wasting thousands of dollars due to poor histology services and not even recognize it? No matter which services you are outsourcing- necropsy, histology, pathology or immunohistochemistry- the best histology lab should be able to stay on-time and within budget. Let’s take a look at 4 signs that you may be wasting time and money on your preclinical research study.