Services: Pathology Consultation

Pathology Peer Review | Pathology Working Groups (PWG)
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Pathology Peer Review

EPL developed peer review approaches in conjunction with the NCI/NTP Carcinogenicity Bioassay Program in the late 1970s.  These procedures have been widely adopted internationally as the preferred approach for peer review of pathology data from all studies performed during drug development.  EPL has provided pathology peer review services to the National Toxicology Program for over 25 years for all subchronic and chronic studies conducted in rats and mice.  We also conduct pathology peer review for pharmaceutical and chemical companies, contract laboratories, and industrial trade organizations in the United States, Canada, Japan, Great Britain, and Europe.

There are many advantages to using EPL to conduct third-party peer review for your studies whether conducted at your facility or at a Contract Research Organization (CRO).  The added value to the study when it reaches the regulatory agencies in the United States, Europe, or Japan include increased credibility with reviewers, increased confidence by the study sponsor, increased accuracy of the data, and potentially reduced scrutiny of the pathology report by the reviewing agency’s compliance groups.  This should result in reduced time to gain regulatory approval of your studies and allow a faster return on your investment.

There are also many intangible benefits that can result from using EPL for third-party peer review of your development programs.  By relying on the experience and expertise of EPL’s peer review pathology staff supported by EPL’s unique computerized peer review software you can be assured that the data are handled in a consistent and complete manner.  EPL pathologists will provide standardized nomenclature and diagnostic criteria across all studies in a drug development program, regardless of the location of the study.  This will allow the study sponsor and the regulatory agencies to easily compare the results of all studies in a submission package.

Currently, peer review is required by regulation only by a few agencies.  The US EPA requires peer review on all submissions requesting re-consideration of carcinogenicity peer review decisions based on changes in the pathology diagnoses.  Additionally, peer review is required for all carcinogenicity studies submitted to the European Agency for the Evaluation of Medicinal Products. While not required by FDA and other regulatory authorities, it is generally recognized that the reliability of pathology diagnoses is greatly enhanced by comprehensive quality assurance and peer review.

EPL’s proprietary peer review software is capable of interfacing with pathology data from all testing laboratories ensuring the accurate transfer of data.  This allows EPL pathologists to follow the protocols included in the standard software, or to change the approach to meet the requirements of the client’s Standard Operating Procedures.