Supporting Patient Facing Registries Case Study
Patient registries are databases designed to provide a real-world view of clinical practice, patient outcomes, safety and comparative effectiveness following regulatory approval of a drug or device. Because patient registry studies are often large and may go on for several years, they need to be flexible, cost-efficient and relatively easy to use and maintain. eClinicalHealth was approached to design a solution using the Clinpal platform for two such studies related to venous thromboembolic events, stroke and systemic embolization, involving more than 15,000 patients speaking 35 different languages/dialects.
The platform used for the studies was Clinpal, a cloud-based 21 CFR Part 11 compliant platform configured for the enrollment and engagement of patients and sites in clinical trials.
The implementations relied on the following standard Clinpal modules:
- Presence — a website for patients and investigative sites
- Capture — electronic patient reported outcome data capture (enabling patients to use their own devices) and advanced electronic site data capture
- Educate — integrated eLearning • Engage — patient dashboard and reminders
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