Case Study

Managing Risks To Time Critical Product Imports At Clinical Supply Depots

Source: Catalent

A Catalent customer wanted to run a clinical trial in Israel and was arranging to ship their clinical trial product from a non-Catalent facility in Europe to a Catalent-managed and audited depot in Israel. With the protocol based in the US and the investigational medical product (IMP) approved in the EU, the customer incorrectly assumed and, without checking further requirements, that Israel had the same QP (qualified person) approval process as the EU.

This case study outlines the steps that Catalent took to ensure the QP release process could quickly advance in Israel while simultaneously updating the warning labels to meet the QP requirements. With seamless communication between Catalent and the Israeli depot team, the customer’s study was able to start on time and support patient screening timelines.