Compelling Real World Evidence (RWE) is increasingly important to support the value proposition of healthcare products and devices.
A foundation of this evidence is dependant on robust real-world studies.
A RWE study can be defined as the collation and analysis of patient-level data other than in randomised controlled clinical trials (RCTs).
Patient-level data can be obtained from a variety of sources, including:
- patient registries
- large scale non-interventional studies or observational studies
- patient chart reviews
- patient clinical audits
- phase IV, post-marketing surveillance or safety studies
- insurance claims databases etc.
A key aspect of RWE studies is that they ‘observe’ treatment and outcomes rather than ‘intervene’ in the clinical management of the patient.
One of the key differences between RWE studies and RCTs and is that in the ‘real world’ the patient sample is likely to have a wider age range, co-morbidities, concomitant medication and varying levels of patient compliance with treatment.
7i Group has substantial expertise in designing and delivering robust RWE studies.
Our proven process is based on the steps shown in this flow chart.
Click below to see case studies of RWE projects the team have delivered.
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