Safety reporting may be the most inefficient aspect of clinical trials today. It’s also among the most expensive, costing sponsors more than $700 million per year. Most are not receiving the best value for their investment, and some don’t even know how much they are spending. Automation has helped resolve some of the challenges, but it has created just as many. The system needs a complete overhaul. It can be done, but it requires the willing to invest in change.