Drive Post-Market Surveillance
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:
- Detect adverse events.
- Compare products and treatments to existing options.
- Comply with regulatory requirements.
- Update and modify clinical guidelines.
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Amplify Post-Market Surveillance With a Clinical Registry
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.
Collect Data from Multiple Sources
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.
Transform Data into Real-World Evidence
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.
Interpret Data to Glean Actionable Insights
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.
Explore Exponential Insights
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:
- Interact with data at a deep clinical level.
- Create patient cohorts, analyze case level details, and draw correlations within and across diagnoses.
- Access all data elements via an easy-to-use query tool and customized extracts of raw and analyzed data.
- Understand significant trends or changes in outcomes.
- Apply custom benchmarking, peer groups and patient cohorts for fair comparisons.
- Engage clinicians, researchers, patients and other stakeholders with meaningful reports, resources and tools.
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Leverage Registry Technology for Post-Market Surveillance
Medical device and pharma companies are using registries to support their post-market surveillance programs in several ways.
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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.
What Is Post-Market Surveillance?
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:
- Detect adverse events or risks as they arise during real-world usage of a device or drug.
- Compare new products or treatments with existing options and the standard of care.
- Update clinical guidelines as certain populations or groups find more benefit than others.
- Comply with regulatory requirements.
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.
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