Case Study

Comparative Analysis For Non-IND Sites

Source: Advarra
Regulatory Landscape of Drug-Device Combination Products

A cancer research organization that facilitates the conduct of multi-national clinical trials was deep in the planning and
coordination of a Phase III drug trial. The sponsor wanted to expand the trial to include German sites and had established important in-country partnerships for this purpose. The trial was being conducted under an IND, and everything was going according to plan until German regulatory authorities changed the rules. The organization needed to determine the feasibility of adding German sites as IND sites and required a comparative analysis—fast.

Read how Advarra Consulting provided in-depth analysis of German, European, and US regulations, allowing the cancer research study to move forward.

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