Registry-based evidence has become an industry standard due to the consistent way in which the data is collected. Whether you need a disease or a product registry, we can support you.
Regulatory authorities increasingly value real-world data and registries in their decision-making processes. Registries can be leveraged throughout the product development process to describe the natural history of a disease, determine the clinical effectiveness or cost-effectiveness of healthcare products and services, measure or monitor safety and harm, and assess the current quality of care. The value derived from a registry is broad and deep, as the data can serve multiple purposes for stakeholders across the industry.
We can help develop custom disease and product registries to suit your specific real-world data needs.
Disease registries include patients suffering from or at risk of a disease, and are an effective way to investigate the natural history of the condition. These registries can inform clinical trial planning by identifying patients for enrollment and generating supplementary evidence as an external control arm.
Our team can also support you in the development of product registries, which provide information about patients treated with a specific product or device.
These registries can be used to fulfill post-marketing authorization requirements for assessing safety, real-world effectiveness, or harm.
The Oracle team of researchers, methodologists, and statisticians brings extensive experience across many therapeutic areas. Our experts identify existing real-world data (RWD) that can be used to create registries. We seek to partner with, and have exclusive access to, databases around the world, leveraging existing RWD to build new registries.
A hybrid approach that combines primary prospective data with existing RWD can also provide more comprehensive answers when needed.
Where the relevant data doesn’t exist, we can assist in the design and creation of new registries via primary data collection with direct-to-patient or site-based methodologies. We have extensive experience identifying existing patient-centered outcomes measures and developing new measures including patient-reported outcomes (PROs).
With more than 40 years of experience and over 1 million patients enrolled in Oracle Life Sciences registries, we’re experts in designing and executing regulatory-grade registries. We’re proud to be a partner of choice for patient advocacy groups such as the International Gaucher Alliance (IGA) and the Cure and Action for Tay-Sachs (CATS) Foundation.
Whether you’re focused on a specific disease and its natural history, or you’re trying to meet your regulatory requirements, we can help identify the best methodology and data to meet your needs.
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