A product's performance in a clinical trial doesn’t tell the full story. You need to understand how it works in the real world, with real patients. When you have access to real-world data organized in a clinical registry, you can generate real-world evidence that can be used for post-market surveillance to:
Patient registries are useful across much of medicine, and post-market surveillance is one of their most valuable purposes. Here are the steps we take to help you create a trusted data resource.
You need an efficient and secure way to collect large amounts of real-world data and prepare it for analysis. With the right technology, you can collect data from medical records, regulatory sources, patient-reported outcomes, and more for post-market surveillance activities.
It takes more than raw data alone to achieve your post-market surveillance goals. Once you collect your data, you need to aggregate, validate, and analyze those various data sources to produce reliable real-world evidence.
With real-world evidence at your fingertips, you can quickly measure clinical outcomes, determine patient quality of life, and understand financial impacts. Our solutions help you make informed decisions and fulfill post-market surveillance requirements.
Our analytics solutions provide you with precise answers that empower evidence-based action. We transform data into useful insights and give you real-time access so you can:
Medical device and pharma companies are using registries to support their post-market surveillance programs in several ways.
Accessing data from an existing registry - like the Extracorporeal Life Support Organization and its medical device registry, ELSO Evidence Explorer.
Partnering with an existing registry that is running registry-based clinical trials - like the Michigan Urologic Surgery Improvement Collaborative (MUSIC) and its randomized clinical trials.
Creating new registries and using existing registry data to support post-market surveillance activities - like Acacia Pharma and its registry-based observational study on post-operative nausea and vomiting.
Post-market surveillance demonstrates the real-world safety and effectiveness of medical devices and pharmaceuticals by collecting, analyzing, and interpreting product or treatment data. It is an active, ongoing process that should provide up-to-date insights that can be used to make adjustments and improvements.
Pharmaceutical and medical device companies rely on the real-world insights they gain through post-market surveillance activities to:
Clinical data registries that collect real-world data, transform it into real-world evidence, and make it accessible are uniquely useful in their ability to facilitate post-market surveillance. They help organizations better understand the real-world safety and effectiveness of their procedures, treatments, and devices so they can make informed decisions moving forward.
Learn more about how post-market surveillance can help your organization.