The ViewPoint FUSE implementation team partnered with a medical device company and industry-leading Late Phase CRO to design and develop an EDC platform for a Late Phase study focusing on safety and standard of care. This was a hybrid study supporting both online and paper-based physicians and patients. Patient reported outcomes were collected directly from patients online and scored in real-time. These real-time scores were aggregated in real-time and displayed to both investigators and the sponsor as clinical benchmark reports. The study utilized the strengths of ViewPoint FUSE’s Auto-Queries, automating 90% of the normal data management functions and dramatically reducing the data management costs. The solution also automated the protocol schedule, making it easy for investigators to know which visits were due and, also automatically reminding them of overdue visits. The study was configured with an SAE notification solution for events reported by physicians.
