The main purpose of a Pathology Peer Review is to improve the quality of the pathology data and narrative. This can be achieved in several ways. A 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 peer review may help to increase the accuracy of the data, thus increasing the confidence in it 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 peer review can also confirm the target organs identified in the original evaluation and confirm the No Observed Effect Level (NOEL). 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.
Peer review also serves as a source of continuing education and training, for both the study pathologist and the reviewing pathologist. In many cases the study pathologist will have a limited amount of experience, and can benefit from the 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 every peer review. EPL’s team of experienced pathologists have been providing peer review services to the NCI/NTP carcinogenesis testing program and commercially for companies in the pharmaceutical, biotechnology and chemical industry for over 30 years. We provide these services to clients in North America, Europe and Asia. When conducting a peer review, we take our team to the testing laboratory where the study pathologist is located. This eliminates the cost and risk associate with shipping the glass microscope slides and by working directly with the study pathologist to finalize the findings speeds up the reporting process.