I had been involved with Fidelis Security and after the company was sold to General Dynamics, I was between gigs. A friend of a friend introduced me to an Israeli CRO who needed some technical assistance in a clinical trial of a medical device in the psychiatric space. I didn't do much but after the customer received their 510(K), the CRO invited me to a cooking class to celebrate the successful submission. The entire clinical space was new and strange to me especially the part of SDV, site visits and all the people and paper-intensive processes.
I was paired off to cook with the study bio-statistician and she lamented how primitive the data collection and monitoring was from her perspective. Coming from Fidelis Security data loss prevention technology that provides automated real-time detection and response; the notion of taking 6 months to clean data seemed about 50 years behind the times.
By the time we finished cooking (and a bottle of wine) - we had the vision: automated real-time detection and response of safety and compliance violations in clinical trials.
The value of real-time detection and response in clinical trials
Time waiting for SDV and site visits is time burning money and delaying revenue.
Consider a pipeline with revenue EU 500M/year that is delayed by 6 months due to non-compliant patients and undetected defects. Every month saved by improving compliance and detection, pulls in EU 41.6M of revenue.