EPL Pathology Peer Review
When selecting a Pathology Peer Review provider, experience is an important factor to consider in order to ensure high quality pathology data. Over the last two years alone, EPL has conducted more than 250 pathology peer reviews. These pathology peer reviews have been conducted internationally, with reviews being performed across North America, Asia, and Europe. For over 30 years, EPL’s team of experienced pathologists have been providing pathology peer reviews commercially for companies in the pharmaceutical, biotechnology and chemical industries, along with providing pathology peer review services to the US NCI/NTP carcinogenesis testing program.
The main purpose of a pathology peer review is to improve the quality of the pathology data and pathology report. This can be achieved in several ways. A pathology peer review can help to ensure that the data are presented in a manner that meets the requirements of the regulatory agency to which the data will be submitted. A pathology peer review helps to increase the accuracy of the data, thus increasing the confidence in the data both for the Sponsor and for the regulatory agencies. This is true whether the study was completed at the Sponsor’s facility, at a Contract Research Organization (CRO), or in an academic laboratory. A pathology peer review can also confirm the target organs identified in the original evaluation and confirm the No Observed Effect Level (NOEL), and/or No Observed Adverse Effect Level (NOAEL).
Our unique PQA software program is a computerized pathology peer review procedure developed at EPL that operates on a portable laptop computer. Study data can be interfaced between the laboratory and EPL’s pathology peer review program through the use of electronic ASCII text files. This assures that the accuracy of the data is maintained during the entire review process and that comparison between the preliminary histopathology data from the laboratory and the pathology quality assurance audit can be made rapidly. In this manner, differences can be easily identified and resolved by the study pathologist and reviewing pathologist, thus allowing the laboratory to complete the draft study report in a timely manner. In areas of the globe, such as Japan and China, where regulators require documentation of all slides reviewed, PQA software produces a ready-made report to satisfy this requirement.
When conducting a pathology peer review, the reviewing pathologist will typically travel to the testing laboratory where the study pathologist is located. Working directly with the study pathologist to finalize the findings creates more efficiency in the reporting process.
Pathology peer review also serves as a source of continuing education and training, for both the study pathologist and the reviewing pathologist. In some cases the study pathologist will have a limited amount of experience, and can benefit from a broader range of experience of the reviewing pathologist. On the other hand, the reviewing pathologist almost always sees something new and learns something different during most peer reviews.
EPL is proud to be a leader in Pathology Peer Review services. Our experience allows us to provide an efficient pathology peer review process, and ensure high quality pathology data.