Issues related to collaboration with outsourcing contractor in the creation of SEND data package for non-clinical contract research organization (CRO)

Abstract

Due to the mandatory submission of SEND (Standard for Exchange of Nonclinical Data) data by the US FDA, many pharmaceutical manufacturers and CROs are increasing their experiences in creating SEND data.

Under this circumstance, for our company or a CRO which does not currently own a SEND data creation system, it is necessary to build a SEND system in cooperation with a partner company.

For this reason, we prepare SEND data of the study conducted at our facility by collaborating with Ina Research Inc., a member of G-SEND (Global SEND Alliance), which is a consortium aiming for uniform and high quality of SEND data between facilities.

When multiple facilities collaborate in creating SEND data, it is a critical issue how to cooperate among the facilities and allocate the operations because it affects the schedule, work (cost) load, and scope of responsibility. Therefore, we used a model study for SEND to prepare SEND data in collaboration with both companies, and examined the optimal work allocation and a scope of responsibility in order to create high-quality SEND data efficiently.

In this presentation, we will summarize the issues and countermeasures when multiple facilities collaborate to create SEND data.