The following case history is based on true events, although references to real individuals and places have been altered to protect the innocent.

Following the relocation of one of my colleagues to another office, I was assigned as his replacement. This was to run one of two pivotal IND Phase III clinical studies being conducted to support marketing applications worldwide. Working as project manager in the UK, I was to report to our product leader in Germany, and was responsible for the worldwide clinical development activities outside of the US.