Our client had received a Warning Letter from the FDA for its conduct of clinical trials and decided to take a proactive, rather than reactive, approach to risk in this area. The brief was to find the critical weaknesses in the end-to-end process before they led to a similar incident.

Our consultant led a team of Green Belts and Black Belts from the client's own staff, running a series of process mapping and FMEA workshops to root out and prioritise key risks. This led to a small number of critical interventions, together with the chartering of approximately 150 Green Belt projects to address the more complex challenges.