What is Real World Evidence (RWE)?
Real World Evidence is generated from the analysis of Real World Data, which is data relating to patient health status and the delivery of healthcare that is routinely collected from various sources. Real World Evidence can be generated by different study designs and analyses, including randomized trials, pragmatic trials, and observational studies (both prospective and retrospective).
Our worldwide routine and specialty laboratory network cover 45 million patient visits per year, during which healthcare professionals routinely collect information on symptoms, treatments, disease status, and biological results in a harmonized and standardized classification.
Health Data Hub
We have developed an internal health data hub that enables us to respond to various statistical data requests, such as studying the frequency of examinations, the prevalence of biological abnormalities, and longitudinal studies of individual biological results for the pharma, biotech, institutional, medical device, and diagnostic customers.
Our team is working on a Real World Evidence request, which requires the collaboration of several key members, including a clinical biostatistician, data analyst, data manager, and project manager. Together, your team will be responsible for extracting, harmonizing, analyzing, and presenting clinical evidence.
The clinical biostatistician will play a critical role in designing the analysis plan, selecting appropriate statistical methods, and interpreting the results to draw meaningful conclusions. They will work closely with the data analyst, who will be responsible for performing the actual data analysis, identifying trends and patterns, and uncovering insights.
The data manager will be responsible for ensuring the quality and integrity of the data used in the analysis. They will work closely with the project manager, who will oversee the entire process, ensuring that timelines are met and all project goals are achieved.
High Quality Reporting
Ultimately, our team’s goal is to produce a final report that provides meaningful insights into the clinical evidence related to the Real World Evidence request. By working together and leveraging each team member’s skills and expertise, we can deliver a high-quality report that meets the needs of our clients. Our health data hub could be paired with public and private external health databases in accordance with current regulations.
The use of Real World Data and evidence is crucial in advancing healthcare, as it can provide insights into the safety and effectiveness of medical products and treatments in realworld settings. The standardized and harmonized collection of data from your network of healthcare professionals can help facilitate the generation of robust Real World Evidence.
Case Study : The Use of RWE to Support Marketing Authorization Approval
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