Outsourcing of routine histopathology of non-clinical safety assessment studies is a viable solution to increasing pressure on reporting deadlines and lack of available personnel. The work needs to be carried out professionally, priced reasonably and on time.
I have over 40 years experience as a “bench pathologist”, reading short- and long-term studies, including carcinogenicity studies.
In general, studies are read using my own PathData software, using my own SOPs and Quality Assurance, and producing a stand-alone GLP compliant report.
It is also possible to read through a VPN on the sponsor’s own PathData , Provantis or Pristima system, under the sponsor’s SOPs and Quality Assurance. This allows the findings to be more closely integrated into the main study report, and has advantages where time is critical, however careful attention must be paid to ensure GLP compliance.
I welcome sponsor peer review of my studies, which can either be done on my premises, or those of the sponsor.
Typical turn-around times for a short term study (40-80 control and high dose animals to be read) are 4-5 weeks to a first draft report, and 4 months for a 600 animal carcinogenicity study. In an emergency situation, or where a study is time-critical, significant reductions in the above times can usually be achieved. Prices are competitive, and I would be pleased to quote for individual studies or larger packages.