A STATEMENT CONCERNING USE OF AUGMENTIQS FOR GLP TELEPATHOLOGY IN PRECLINICAL PEER REVIEW IN GLP STUDIES
Charles River Laboratories (CRL), www.criver.com is one of the world’s largest Contract Research Organizations, boasting 80 sites in 23 countries, and nearly $2 billion in annual revenues. Conducting research for every major pharmaceutical company in the world, CRL employs over 100 toxicologic pathologists who are involved in the toxicologic research of 80% of FDA approved drugs.
Founded in 1947, CRL has grown into today’s leading CRO by focusing on good science, organizational growth and cost-based metrics.
Pathology evaluation is the limiting step in toxicological studies, with sponsors and study pathologists frequently consulting or conducting a peer-review. In the event of disagreement between the pathologists, the slides must be reviewed together to reach a consensus. Today, the ultimate and most frequently used method for peer review is to fly or ship the slides – both of which are costly and time consuming.
As a method for reducing costs, speeding up study time, and improving satisfaction of the sponsor, CRL has instituted the use of Augmentiqs real-time telepathology for some of their GLP preclinical studies. As per the regulatory status of Augmentiqs or any other telepathology solution, the QA department at CRL has shared the following statement.
The histopathology primary evaluation and peer review are evaluated using the appropriate Standard Operating Procedures (SOP), respecting the GLP regulations. The study pathologist (SP) and peer review pathologist (PRP) evaluate the glass slide specimens which provides the basis for data entry, the pathology report, and peer review statement (Morton et al, 2010).
The use of the Augmentiqs system for live histopathology sessions by the SP and PRP serves for illustrative purposes, without any QA audit or regulatory issues. Digital images may be taken for illustrative purposes (Tuomari et. al, 2007). These images are not used for data generation or interpretation, and will not be archived or included in the final report.
If in their professional judgement the SP and PRP conclude that digital images shared by any means are not sufficient for Peer Review consensus, then they would request consensus by other means such as a face to face review of glass slides (Morton et. Al, 2010).
Morton D, Sellers RS, Barale-Thomas E, Bolon B, George C, Hardisty JF, Irizarry A, McKay JS, Odin M, Teranishi M (2010). Recommendations for pathology peer review. Toxicol Pathol. 38:1118-27.
Tuomari DL, Kemp RK, Sellers R, Yarrington JT, Geoly FJ, Fouillet XL, Dybdal N, Perry R(2007). Society of Toxicologic Pathology. Society of Toxicologic Pathology position paper on pathology image data: compliance with 21 CFR Parts 58 and 11. Toxicol Pathol. 35(3):450-5.