Indication: Paroxysmal Noctural Hemoglobinuria
Type of Study: Prospective, observational patient registry
Sponsor: U.S. pharmaceutical Company
Patient Population: 1200
Investigative Sites: 450
The ViewPoint FUSE Team developed an on-line EDC solution for a pharmaceutical company and CRO in support of a prospective, observational study of patients diagnosed with a hematological disorder. Approximately 1,200 patients were enrolled at 450 sites located throughout North America, Australia, Europe and Japan. Data was collected directly from patients and health care providers via electronic patient questionnaires translated into six different languages. Patients were followed for a period of seven years. Real-time project management and clinical benchmark reports were provided to track study progress, data cleanliness and patient outcomes. The solution allowed collection of data during regular study visits and during ad-hoc physician office visits. A training website was also be provided to the sites for the practice of entering dummy data without affecting the integrity of the study database.
