Abstract
Pharmaceutical companies outsource some or all of the safety studies, including GLP, to a non-clinical CRO (Contract Research Organization) to evaluate new drug candidates. The number of outsourced studies is increasing year by year, making non-clinical CROs indispensable partners for pharmaceutical companies.
In the case of outsourced studies, the final interpretation regarding the evaluation of the obtained study results is made by the study director of the contractor (non-clinical CRO), but in the process, the study director has scientific discussions with the clients (e.g., pharmaceutical companies). Although regulations regarding compliance monitoring such as GLP-related Japanese regulations and OECD Series No. 21 exist in discussions between the contractor and the clients, the details are not described, so that the way to proceed differs depending on each facility.
Furthermore, an increasing number of non-clinical CRO companies are able to measure new toxicity biomarkers that have been used in recent years, in addition to the traditional clinical pathology parameters normally measured in toxicity studies. In that case, the non-clinical CRO may also provide information necessary for toxicity evaluation regarding biomarkers (such as background values of biomarkers and study results using model animals).
In light of the situation, this presentation will introduce the difference in viewpoints between the contractor and the client in scientific discussions regarding clinical pathology results, based on the speaker's experience.
I hope the whole audience will participate in the comprehensive discussion during the final session of the symposium.
