The Sponsor is a pharmaceutical company focused on the discovery, development and eventual commercialization of innovative, new medicines for neurodegenerative diseases. The Sponsor has its headquarters in Asia and research and development facilities across Europe.
The Sponsor wanted to continue supplying its investigational product to patients who had completed its Phase 3 clinical trial. A traditional OLEX study was an option. However, the company did not require any formal post-trail data collection.
As such, it wanted to find a cost- and time-effective alternative so that patients were not left without treatment, while waiting for product approval and commercialization.